MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-07-14 for ERA 3000 DE/EN 128828 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[6056885]
Ous mdr - it was reported that an asystole occurred during the implantation of a pacemaker in a pacemaker-dependent patient while the lead was being connected. Pacing via this era 3000 was not possible. Resuscitation via cardiac massaging was necessary. The external device was returned to biotronik for analysis.
Patient Sequence No: 1, Text Type: D, B5
[46375265]
The returned pacing threshold measurement device, including three batteries, was thoroughly analyzed. The device showed damage and missing parts at the housing. Further analysis showed that the power supply and pacemaker circuit boards were severely damaged. Based on the kind of damage, it can be assumed that the device was damaged during the described external defibrillation, so that the original trigger for the clinical observation could no longer be determined. In addition, the batteries were examined. The sn (b)(4) was defect, the two other batteries did not show any deviations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2015-02515 |
| MDR Report Key | 4911827 |
| Report Source | * |
| Date Received | 2015-07-14 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-06-08 |
| Date Mfgr Received | 2016-05-25 |
| Device Manufacturer Date | 2006-09-14 |
| Date Added to Maude | 2015-07-14 |
| 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 | 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 | ERA 3000 DE/EN |
| Generic Name | PACING SYSTEM ANALYZER |
| Product Code | DTA |
| Date Received | 2015-07-14 |
| Model Number | 128828 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-07-14 |