MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-09-12 for DEXTRUS 4135 358744 manufactured by Biotronik Se & Co. Kg.
[2881702]
Boston scientific received info that following pocket closure at a routine implant procedure, the right atrial lead was noted to not sense appropriately. The pt implanted with this lead was in atrial fibrillation. Fluoroscopy was performed and the ra had notably dislodged. A revision procedure was performed and the ra lead was explanted. The ra port was plugged due to the pt? S medical condition. No adverse pt effects were reported during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2012-02245 |
| MDR Report Key | 2747845 |
| Report Source | 01,07 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-08-28 |
| Date of Event | 2012-08-03 |
| Date Mfgr Received | 2012-08-28 |
| Date Added to Maude | 2012-09-19 |
| 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 | 8772459800 |
| 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 | DEXTRUS 4135 |
| Generic Name | PACER LEAD |
| Product Code | IZO |
| Date Received | 2012-09-12 |
| Model Number | 358744 |
| Catalog Number | 358744 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-09-12 |