MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-11 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[30983485]
Ous mdr - the following is what was reported:at 12:30 the monitor of my patient has started alarming for ventricular tachycardia. The pacing box the patient was connected to started firing at 120 - 140 bpm. This pacing box was set as a backup with the parameters: mode:ddd, rate:60, av delay:200, atrial sensitivity:0. 3, atrial output: 6, ventricular sensitivity: 6, ventricular output: 10. Immediately contacted with a senior nurse who changed the parameters of the pacing box and reduced the rate until 40; however, even after these changes, the pacing box was still firing at the same rate. The patient had an underlying rhythm of sinus rhythm with bundle branch block of 80-95 bpm. The device has been returned for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2015-04044 |
| MDR Report Key | 5217014 |
| Date Received | 2015-11-11 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-09-24 |
| Date Mfgr Received | 2015-10-29 |
| Date Added to Maude | 2015-11-11 |
| 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 D |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2015-11-11 |
| Model Number | 365529 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN 12359 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-11-11 |