MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-07-02 for PHILOS DR 122450 manufactured by Biotronik Se & Co. Kg.
[2770801]
Ous mdr? After an implant time of about 78 months, it was reported that the pt lost consciousness on (b)(6) 2011. The ecg showed a loss of capture, but the follow up on (b)(6) detected nothing abnormal. The sensing of the ventricular was on unipolar. It was re-programmed to bipolar. On (b)(6), a 24 h ecg was performed showing ventricular sensing in unipolar. No event was detected. The device was re-programmed to bipolar sensing. Since this follow-up, no new event were reported. When explanting the device in (b)(6) 2012, the cardiologist suspected a default of the insulation of the device and sent it back for analysis.
Patient Sequence No: 1, Text Type: D, B5
[10098112]
Ous mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2012-01714 |
| MDR Report Key | 2654549 |
| Report Source | 01,07 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-06-22 |
| Date of Event | 2011-07-14 |
| Date Mfgr Received | 2012-06-22 |
| Date Added to Maude | 2012-08-15 |
| 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 | PHILOS DR |
| Generic Name | PACEMAKER |
| Product Code | IZO |
| Date Received | 2012-07-02 |
| Model Number | 122450 |
| Catalog Number | 122450 |
| 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. Hospitalization | 2012-07-02 |