MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2010-11-12 for KENTROX SL 65/16 STEROID 347351 manufactured by Biotronik Se & Co. Kg.
[1649687]
This system was explanted due to inappropriate shocks. No adverse pt side effects have been reported. The date of implant was not provided.
Patient Sequence No: 1, Text Type: D, B5
[8977628]
Upon receipt, the lead was found dissected some 19 cm distal to the is-1 connector pin. Only the proximal part of the lead was received. It is reasonable to assume that the lead was dissected in the course of the surgery. Due to the damages the electrical inspection of the lead was limited to the dc resistances of the lead fragment. No peculiarities were found. The analysis did not reveal any sign of a material or manufacturing problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2010-02364 |
| MDR Report Key | 1902816 |
| Report Source | 01,07 |
| Date Received | 2010-11-12 |
| Date of Report | 2010-10-20 |
| Date of Event | 2010-06-23 |
| Date Mfgr Received | 2010-10-20 |
| Device Manufacturer Date | 2006-08-28 |
| Date Added to Maude | 2010-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8005470394 |
| Manufacturer G1 | BIOTRONIK SE & CO. KG |
| Manufacturer City | BERLIN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KENTROX SL 65/16 STEROID |
| Generic Name | ICD LEAD |
| Product Code | DTA |
| Date Received | 2010-11-12 |
| Model Number | 347351 |
| Catalog Number | 347351 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | BERLIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-11-12 |