MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-11 for BIOMONITOR III 436066 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[178595234]
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance. As of today, the medical device is not available for analysis, therefore the device itself could not be investigated. The information you provided has been entered into our quality system as a complaint. These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices. Should additional relevant information or the device itself become available, the investigation will be updated.
Patient Sequence No: 1, Text Type: N, H10
[178595235]
Device reported several false asystole detections and recordings on home monitoring between (b)(6) 2019 and (b)(6) 2020. Interrogation was attempted on (b)(6), but was unsuccessful. The location of the device could not be confirmed by palpation. No surgical intervention occurred at the time. On (b)(6), it was reported that the device had externalized on an unknown date and is no longer in the body. A new device has not been implanted. Should additional information become available, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-00684 |
| MDR Report Key | 9693627 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-02-09 |
| Device Manufacturer Date | 2019-09-18 |
| Date Added to Maude | 2020-02-11 |
| 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 |
| 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 III |
| Generic Name | IMPLANTABLE CARDIAC MONITOR |
| Product Code | MXD |
| Date Received | 2020-02-11 |
| Model Number | 436066 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-11 |