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 2020-03-20 for VERCISE CARTESIA DB-2202-45 manufactured by Boston Scientific Neuromodulation.
[184444109]
Additional suspect medical device components involved in the event: brand name: vercise cartesia, upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5127050. Brand name: vercise cartesia, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7014959 and 7028946.
Patient Sequence No: 1, Text Type: N, H10
[184444110]
It was reported that the patient underwent an explant procedure of the leads and lead extensions. The patient fell, which was not device related, in january and sustained several injuries, one of which was that the lead incision site behind her ear tore open and exposed the lead and lead extension. The patient was prescribed antibiotics. About seven weeks after the fall the patients wound was assessed by the physician in the operating room. At that time the physician elected to explant the devices to allow the patient to fully heal. The patient is doing well post operatively. The devices were not released by the facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-01340 |
| MDR Report Key | 9863046 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-02-14 |
| Date Added to Maude | 2020-03-20 |
| 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 | ROAD 698, LOT NO. 12 |
| Manufacturer City | DORADO PR 00646-260 |
| Manufacturer Country | RQ |
| Manufacturer Postal Code | 00646-2602 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERCISE CARTESIA |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS |
| Product Code | NHL |
| Date Received | 2020-03-20 |
| Model Number | DB-2202-45 |
| Catalog Number | DB-2202-45 |
| Lot Number | 5128306 |
| 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 | 2020-03-20 |