MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-05-05 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[5824528]
Ous mdr - the clinic states that their biomedical maintenance service identified a loss of sensing on the last four devices (external pacemakers) acquired in (b)(6) 2014. They felt that -the pacemaker should beep continuously if the impedance is equal or greater than 10,000 ohms or if the impedance is equal or less than 50 ohms, but these 4 devices did not respond in the tests performed at equal or below 50 ohms. This loss of response was not observed with similar devices of the older generation. There were no patient interactions when these tests were being performed.
Patient Sequence No: 1, Text Type: D, B5
[13324292]
We received your event description for the above mentioned devices and the observation of the clinical user can be retraced in our quality and production documentation of the device. The observations are correct and according to the expected device behavior. The described missing alarm is no deviation of the device specification. During market observations in the past distracting and unnecessary false alarms due to low impedances were stated. The cause might be too close placed heart wires or the use of low resistive wires of different manufacturers. The alarm for the low impedance of reocor was therefore considered too sensitive and was deactivated. The risk assessment, as well as the user manual, was adapted accordingly. However, high impedances might be critical for the patient for instance by accidently disconnecting the external pacemaker. Thus the warning threshold for high impedances stays unmodified. As of today, the medical device is not available for analysis; therefore, the device itself could not be investigated. Should additional relevant information or the device itself become available, the investigation will be updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2015-01470 |
| MDR Report Key | 4748442 |
| Report Source | * |
| Date Received | 2015-05-05 |
| Date of Report | 2015-04-24 |
| Date Mfgr Received | 2015-04-24 |
| Device Manufacturer Date | 2013-03-22 |
| Date Added to Maude | 2015-05-05 |
| 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 | REOCOR D |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2015-05-05 |
| Model Number | 365529 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-05-05 |