MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-03-28 for LEXOS DR-T 347001 manufactured by Biotronik Gmbh And Co..
[810048]
Per call to rep. This device was removed because of eri indication after an implantation time of about 2 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2008-00285 |
| MDR Report Key | 1020530 |
| Report Source | 07 |
| Date Received | 2008-03-28 |
| Date of Report | 2008-02-28 |
| Date of Event | 2008-01-23 |
| Date Mfgr Received | 2008-02-28 |
| Date Added to Maude | 2008-04-03 |
| 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, GMBH AND CO |
| Manufacturer City | BERLIN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEXOS DR-T |
| Generic Name | ICD |
| Product Code | LPQ |
| Date Received | 2008-03-28 |
| Model Number | 347001 |
| Catalog Number | 347001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 988481 |
| Manufacturer | BIOTRONIK GMBH AND CO. |
| Manufacturer Address | BERLIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-03-28 |