MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-10-03 for RELIATY 365530 manufactured by Biotronik Se & Co Kg.
[3072554]
Ous mdr - it was reported that the reliaty device jumped form ddd to adi mode during the pacemaker exchange without any external influence. No deterioration of the pt's state of health was reported.
Patient Sequence No: 1, Text Type: D, B5
[10191459]
Ous mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2012-02456 |
| MDR Report Key | 2785831 |
| Report Source | 01,07 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-09-20 |
| Date Mfgr Received | 2012-09-20 |
| Date Added to Maude | 2012-11-14 |
| 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 | RELIATY |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2012-10-03 |
| Model Number | 365530 |
| Catalog Number | 365530 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO KG |
| Manufacturer Address | BERLIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-03 |