MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-03 for REOCOR S REDEL ADAPTER 371263 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[63799956]
Upon receipt, the external pacemaker including the redel adapter was inspected. It was not possible to turn the external pacemaker on in the delivered state. The inspection of the outer assembly revealed a blocked battery compartment. Opening the device the protective cap of the 9 volt block battery was found to be stuck in the battery compartment. Apparently it had been forgotten to be removed before inserting the battery. Therefore the compartment did not close correctly. A safe power supply of the device was not possible because of this. In a next step the inner assembly of the external pacemaker and the adapter was inspected and the functionality of the electronic module was checked. During the analysis, it was revealed that the electronic module was damaged. The damage symptoms clearly indicate an external defibrillation. The device stimulation functions are not longer available due to this. The visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem, but external damages due to user handling.
Patient Sequence No: 1, Text Type: N, H10
[63799957]
It was reported that the external pacemaker did not turn on and did not stimulate. The external pacemaker, with the adapter, was returned to biotronik for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2016-05186 |
| MDR Report Key | 6220604 |
| Date Received | 2017-01-03 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-07-11 |
| Date Mfgr Received | 2016-12-15 |
| Device Manufacturer Date | 2016-01-20 |
| Date Added to Maude | 2017-01-03 |
| 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 | 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 | 2017-01-03 |
| 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 | 2017-01-03 |