MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-03-13 for RELIATY 365530L SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[5628022]
The representative reports that during a case on a dependent patient the reality stopped pacing and there was intermittent sensing. The reality was connected electrically to power. Normal pacing function was observed when the leads were connected to the pacemaker.
Patient Sequence No: 1, Text Type: D, B5
[31639908]
Upon receipt, the pacing system analyzer was inspected. Despite the damaged case stands, which were replaced, 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 | 1028232-2015-00780 |
| MDR Report Key | 4601419 |
| Report Source | * |
| Date Received | 2015-03-13 |
| Date of Report | 2015-02-27 |
| Date of Event | 2015-02-27 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2012-12-14 |
| Date Added to Maude | 2015-03-13 |
| 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 | RELIATY |
| Generic Name | EXTERNAL PSA |
| Product Code | OVJ |
| Date Received | 2015-03-13 |
| Model Number | 365530L |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization | 2015-03-13 |