The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Articles - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
Rappel de INTELECT ADVANCED THERAPY SYSTEMS
Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CHATTANOOGA GROUP A DIVISION OF ENCORE MEDICAL L.P..
Qu'est-ce que c'est?
Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.
En savoir plus sur les données ici-
Type d'événement
Recall
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ID de l'événement
77749
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Classe de risque de l'événement
II
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Date de mise en oeuvre de l'événement
2008-08-15
- Pays de l'événement
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Source de l'événement
HC
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Notes / Alertes
Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada. -
Notes supplémentaires dans les données
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Cause
Electronic components of the printed circuit board (pcb) could malfunction causing the pcb to change the stimulator patient output resulting in a shock sensation and possible burn beneath the electrode.
Device
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Modèle / numéro de série
Model Catalog: 2765CS (Lot serial: serial # 1000-1017 (2755CS)); Model Catalog: 2778 (Lot serial: serial # 1000-2799 (2777)); Model Catalog: 2777 (Lot serial: serial # 1000-3541 (2778)); Model Catalog: 2778 (Lot serial: serial # 1000-3541 (2778)); Model Catalog: 2761 (Lot serial: serial # 1000-5047 (2761)); Model Catalog: 2764 (Lot serial: serial # 1000-5047 (2761)); Model Catalog: 2761 (Lot serial: serial # 1000-1713 (2764)); Model Catalog: 2764 (Lot serial: serial # 1000-1713 (2764)); Model Catalog: 2783 (Lot serial: serial # 1000-1615 (2783)); Model Catalog: 2760 (Lot serial: serial # 100-1683 (2763)); Model Catalog: 2763 (Lot serial: serial # 100-1683 (2763)); Model Catalog: 2760 (Lot serial: serial # 1000-5886 (2760)); Model Catalog: 2763 (Lot serial: serial # 1000-5886 (2760)); Model Catalog: 2773MS (Lot serial: serial # 1000-3002 (2772MC)); Model Catalog: 2772MC (Lot serial: serial # 1000-3002 (2772MC)); Model Catalog: 2765CS (Lot serial: serial # 1000-3002 (2772MC)); Model Catalog: 2762CC (Lot serial
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Description du dispositif
INTELECT ADVANCED THERAPY SYSTEMS
- Manufacturer
Manufacturer
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Adresse du fabricant
HIXSON
- Société-mère du fabricant (2017)
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Source
HC