Devices

Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.

  • Modèle / numéro de série
    Part number 330444. Serial numbers 78110211, 78110212, 78110215, 78110226, 78110227, 78110229, 78110231, 78110233, 78110234, 78110235, 78110270, 78110287, 78110288, 78110290, 78110292, 78110294, 78110295, 78110296, 78110297, 78110298, 78110299, 78110300, 78110302, 78110303, 78110305, 78110306, 78110307, 78110308, 78110309, 78110310, 78110315, 78110316, 78110318, 78110325, 78110331, 78110335, 78110336, 78110337, 78110339, 78110340, 78110341, 78110342, 78110344, 78110345, 78110347, 78110348, 78110349, 78110351, 78110352, 78110361, 78110362, 78110363, 78110364, 78110365, 78110376, 78110378, 78110380, 78110387, 78110388, 78110390, 78110401, 78110402, 78110403, 78110404, 78110405, 78110406, 78110407, 78110408, 78110411, 78110412, 78110413, 78110414, 78110416, 78110417, 78110418, 78110420, 78110421, 78110454, 78110455, 78110457, 78110459, 78110461, 78110462, 78110463, 78110464, 78110465, 78110466, 78110467, 78110468, 78110469, 78110470, 78110471, 78110472, 78110477, 78110479, 78110483, 78110484, 78110485, 78110486, 78110487, 78110488, 78110494, 78110496, 78110497, 78110501, 78110504, 78110505, 78110507, 78110510, 78110511, 78110512, 78110513, 78110520, 78110525, 78110526, 78110530, 78110535, 78110536, 78110537, 78110538, 78110539, 78110540, 78110541, 78110542, 78110544, 78110545, 78110546, 78110547, 78110550, 78110551, 78110559, 78110561, 78110565, 78110566, 78110568, 78110569, 78110571, 78110572, 78110574, 78110575, 78110576, 78110577, 78110579, 78110585, 78110587, 78110588, 78110589, 78110592, 78110595, 78110596, 78110597, 78110598, 78110599, 78110600, 78110601, 78110602, 78110603, 78110604, 78110605, 78110606, 78110608, 78110609, 78110611, 78110612, 78110614, 78110621, 78110627, 78110628, 78110629, 78110632, 78110633, 78110634, 78110636, 78110639, 78110641, 78110642, 78110643, 78110650, 78110651, 78110658, 78110690, 78110691, 78110692, 78110694, 78110704, 78110705, 78110706, 78110766, 78110773, 78110786, 78110789, 78110791, 78110793, 78110795, 78110799, 78110800, 78110811, 78110814, 78110815, 78110823, 78110824, 78110827, 78110828, 78110833, 78110835, 78110838, 78110843, 78110844, 78110845, 78110856, 78110857, 78110865, 78110866, 78110867, 78110870, 78110872, 78110875, 78110876, 78110877, 78110878, 78110879, 78110880, 78110881, 78110882, 78110883, 78110884, 78110885, 78110897, 78110905, 78110906, 78110907, 78111001, 78111002, 78111003, 78111005, 78111006, 78111021, 78111022, 78111023, 78111024, 78111025, 78111071, 78111076, 78111079, 78111080, 78111091, 78111092, 78111096, 78111097, 78111142, 78111148, 78111150, 78111155, 78111162, 78111171, 78111181, 78111201, 78111203, 78111206, 78111207, 78111208, 78111210, 78111220, 78111231, 78111239, 78111257, 78111259, 78111260, 78111261, 78111270, 78111276, 78111277, 78111278, 78111279, 78111280, 78111281, 78111282, 78111283, 78111290, 78111294, 78111296, 78111297, 78111313, 78111316, 78111327, 78111328, 78111330, 78111331, 78111333, 78111334, 78111335, 78111336, 78111337, 78111339, 78111340, 78111341, 78111343, 78111345, 78111351, 78111353, 78111361, 78111362, 78111406, 78111409, 78111430, 78111439, 78111440, 78111444, 78111447, 78111448, 78111449, 78111496, 78111498, 78111502, 78111517, 78111519, 78111520, 78111522, 78111594, 78111655, 78111666, 78111667, 78111668, 78111669, 78111802, 78111828, 78111832, 78111839, 78111840, 78111841, 78111843, 78111844, 78111845, 78111846, 78111888, 78111900, 78111901, 78111902, 78111909, 78111911, 78111912, 78111913, 78111914, 78111915, 78111917, 78111918, 78111924, 78111961, 78111979, 78111980, 78111982, 78111985, 78111993, 78111994, 78111995, 78111996, 78111997, 78111998, 78112018, 78112029, 78112045, 78112046, 78112100, 78112105, 78112111, 78112112, 78112113, 78112114, 78112116, 78112117, 78112120, 78112149, 78112150, 78112151, 78112158, 78112162, 78112163, 78112178, 78112180, 78112182, 78112201, 78112211, 78112225, 78112226, 78112235, 78112244, 78112258, 78112259, 78112260, 78112261, 78112267, 78112285, 78112294, 78112295, 78112296, 78112297, 78112300, 78112302, 78112303, 78112310, 78112312, 78112314, 78112315, 78112316, 78112317, 78112318, 78112319, 78112321, 78112322, 78112323, 78112324, 78112325, 78112327, 78112338, 78112339, 78112345, 78112346, 78112349, 78112350, 78112360, 78112361, 78112362, 78112377, 78112381, 78112384, 78112387, 78112388, 78112389, 78112392, 78112446, 78112477, 78112478, 78112493, 78112494, 78112495, 78112496, 78112497, 78112500, 78112503, 78112504, 78112506, 78112507, 78112508, 78112509, 78112549, 78112550, 78112552, 78112554, 78112555, 78112556, 78112557, 78112613, 78112614, 78112615, 78112617, 78112618, 78112619, 78112620, 78112621, 78112622, 78112623, 78112624, 78112644, 78112645, 78112647, 78112648, 78112676, 78112831, 78112835
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    The firm distributed to physicians throughout the United States. The firm only distributes to US customers.
  • Description du dispositif
    Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter Defibrillators. The Belos VR is a single-chamber implantable cardioverter defibrillator (ICD) that detects and treats ventricular tachyarrhythmias and provides rate adaptive bradycardia pacing support. The ICDs are designed to collect diagnostic data to aid the physician''s assessment of a patient''s condition and the performance of the implanted device.
  • Manufacturer
    Biotronik Inc
  • 1 Event

Fabricant

Biotronik Inc
  • Adresse du fabricant
    Biotronik Inc, 6024 Jean Road, Lake Oswego OR 97035-5369
  • Commentaire du fabricant
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA