MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-06 for BIOMONITOR 2-AF 398493 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[182567418]
The device was received for analysis. Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated and all production steps were performed accordingly. During initial device interrogation a warning message was triggered regarding the battery condition, as mentioned in the complaint description. The battery status was eri, which was detected on 4-aug-2019. The memory content documented a normal and expected current consumption, however, an inconsistency between current consumption and battery voltage was noted. Therefore the device was opened and subjected to further investigation. The visual inspection of the inner assembly showed no anomalies. The measurement of the battery voltage confirmed a depleted battery. The battery was disconnected from the electronic module. Further thorough investigation of the electronic module did not show any anomalies. In particular the current consumption proved to be normal and expected. The battery was sent to the manufacturer for further analysis. The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the manufacturing. No anomalies were documented during the production process, associated with this battery. The battery was subjected to a visual and an electrical inspection as well as a microcalorimetry analysis. The visual inspection of the battery did not reveal any external signs of damage. The measurement of the battery voltage confirmed a depleted battery. The microcalorimetry showed an elevated heat dissipation. Next, the battery was opened for destructive analysis. The inspection of the inner assembly identified damaged insulation, which led to an elevated internal self-depletion within the battery and therefore contributed to the clinical observation. In conclusion, an elevated internal self-depletion within the battery was found to be the root cause for the clinical observation.
Patient Sequence No: 1, Text Type: N, H10
[182567419]
This device was explanted and replaced due to eri. The manufacturers analysis revealed a battery issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01125 |
| MDR Report Key | 9800600 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-06 |
| Date of Report | 2019-08-08 |
| Date of Event | 2019-08-08 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BIOMONITOR 2-AF |
| Generic Name | IMPLANTABLE CARDIAC MONITOR |
| Product Code | MXD |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2019-09-10 |
| Model Number | 398493 |
| Catalog Number | SEE MODEL NO. |
| Device Expiration Date | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN 12359 DE 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-06 |