MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-30 for VERCISE GEVIA DB-1200-S manufactured by Boston Scientific Neuromodulation.
[177014362]
A report was received that the patient was having difficulty charging the ipg. The patient indicated that she had to apply extreme pressure to be able to couple to the ipg, and did not use a spacer which would then trigger the thermistor causing the charger to turn off. The patient also iced the area and used patches and that was also ineffective. An x-ray was taken which confirmed that the ipg was flipped in the ipg pocket causing the charging problem due to subcutaneous depth. The patient underwent a revision procedure in which the ipg was flipped back. The charging difficulty has been resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00282 |
| MDR Report Key | 9648587 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-07-09 |
| Date Added to Maude | 2020-01-30 |
| 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 Contact | TALAR TAHMASIAN |
| Manufacturer Street | 25155 RYE CANYON LOOP |
| Manufacturer City | VALENCIA CA 91355 |
| Manufacturer Country | US |
| Manufacturer Postal | 91355 |
| Manufacturer Phone | 6619494863 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERCISE GEVIA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS |
| Product Code | NHL |
| Date Received | 2020-01-30 |
| Model Number | DB-1200-S |
| Catalog Number | DB-1200-S |
| Lot Number | 739110 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC NEUROMODULATION |
| Manufacturer Address | 25155 RYE CANYON LOOP VALENCIA CA 91355 US 91355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-30 |