MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-08-19 for REOCOR D REDEL ADAPTER 371262 manufactured by Biotronik Se & Co. Kg.
[18025728]
Ous mdr - this external pacemaker is reported to be not capturing properly. This is all of the information that was provided. If additional information is obtained, this event will be updated.
Patient Sequence No: 1, Text Type: D, B5
[18118658]
Upon receipt, the external pacemaker including redel adapter was inspected. Despite a damaged case and a bent set screw, which were repaired, the device did not show any deviation during analysis. No indication which might have contributed to the clinical observation was revealed. The visual, mechanical and functional analysis revealed no anomalies and no material or manufacturing deviation was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2014-02904 |
| MDR Report Key | 4036405 |
| Report Source | 01,07 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-08-04 |
| Date Mfgr Received | 2014-08-04 |
| Device Manufacturer Date | 2010-11-11 |
| Date Added to Maude | 2014-09-03 |
| 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 | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REOCOR D REDEL ADAPTER |
| Generic Name | EXTERNAL PACEMAKER ADAPTER |
| Product Code | OVJ |
| Date Received | 2014-08-19 |
| Model Number | 371262 |
| Catalog Number | 371262 |
| 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 | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-19 |