MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-28 for REOCOR S REDEL ADAPTER 371263 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[55872983]
Upon receipt, the external pacemaker including the redel adapter was inspected. The visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem. In particular no deviation of the stimulation behavior could be observed. In conclusion no deviation related to the clinical observation was found during analysis.
Patient Sequence No: 1, Text Type: N, H10
[55872984]
It was reported that the external pacemaker did not stimulate while it was connected to a patient. The pacemaker was returned to biotronik for analysis. No adverse patient side effects have been reported. The event date was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2016-03472 |
| MDR Report Key | 5985092 |
| Date Received | 2016-09-28 |
| Date of Report | 2016-08-29 |
| Date Mfgr Received | 2016-08-29 |
| Device Manufacturer Date | 2014-07-24 |
| Date Added to Maude | 2016-09-28 |
| 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 | 3 |
| Event Location | 3 |
| 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 S REDEL ADAPTER |
| Generic Name | EXTERNAL PACEMAKER ADAPTER |
| Product Code | OVJ |
| Date Received | 2016-09-28 |
| Model Number | 371263 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-09-28 |