MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for ITREVIA 5 DR-T DF4 PROMRI 392421 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[185493785]
The icd was not returned for analysis. The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data. The manufacturing process for this device was reinvestigated and all production steps were performed accordingly. There was no sign of any inconsistency during the manufacturing process. Particularly the final acceptance test proved the device functions to be as specified. The returned device data was inspected. The inspection confirmed the eos battery status. Eos was detected on (b)(6) 2020 at 12:52 and led to a notification via home monitoring to ensure patient safety. The data further showed a detection of strong magnetic fields at 12:26, 26 minutes before the eos detection, most probably due to the beginning of the mentioned mri scan. The mri mode of the device was not activated. Please note that an mri scan without prior programming the device into mri mode is not recommended because of possible subsequent damage to the electronic module. Should additional relevant information become available, this investigation will be updated.
Patient Sequence No: 1, Text Type: N, H10
[185493786]
Eos detected via home monitoring after an mri on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01461 |
| MDR Report Key | 9886112 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-23 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2017-07-10 |
| Date Added to Maude | 2020-03-26 |
| 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 | ITREVIA 5 DR-T DF4 PROMRI |
| Generic Name | ICD |
| Product Code | MRM |
| Date Received | 2020-03-26 |
| Model Number | 392421 |
| Catalog Number | SEE MODEL NO. |
| Device Expiration Date | 2019-01-31 |
| 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 12359 DE 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |