MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-03-05 for DEXTRUS 4136 358754 manufactured by Biotronik Se & Co. Kg.
[2553726]
Boston scientific received information that this right ventricular lead was repositioned due to intermittent capture at maximum output due to high thresholds. No asystole was observed. The initial issue was noted during a routine follow-up in which the patient did not feel well. The lead was repositioned successfully. The lead remains in service. No further information is available. This report will be updated if more information becomes available.
Patient Sequence No: 1, Text Type: D, B5
[9669927]
The device was not returned for analysis. The analysis is therefore based on the inspection of the quality documents accompanying this particular device. The manufacturing process for this device was re-investigated. All production steps had been performed accordingly. There was no sign of any inconsistency during the manufacturing process, which might be related to the clinical observation. In summary, the device was not returned for analysis. The review of the quality documents confirmed a regular device manufacturing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2012-00501 |
| MDR Report Key | 2483809 |
| Report Source | 01,07 |
| Date Received | 2012-03-05 |
| Date of Report | 2012-02-21 |
| Date of Event | 2012-01-09 |
| Date Mfgr Received | 2012-02-21 |
| Device Manufacturer Date | 2011-07-16 |
| Date Added to Maude | 2012-03-09 |
| 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 | 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 4136 |
| Generic Name | PACER LEAD |
| Product Code | IZO |
| Date Received | 2012-03-05 |
| Model Number | 358754 |
| Catalog Number | 358754 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | BERLIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-05 |