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 2020-02-04 for VERCISE CARTESIA DB-2202-45 manufactured by Boston Scientific Neuromodulation.
[177536625]
Additional suspect medical device component involved in the event: product family: dbs-linear leads upn: (b)(4), model: db-2202-45, serial: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177536626]
It was reported that the patients lead site neck incision was not healing properly after an implant procedure. The physician washed the wound out and added a layer of dissolvable sutures and staples. No infection was present but the patient was administered antibiotics. It was noted that the patient was dirty and had been wearing a heavily soiled sweatshirt with dried blood clots around the collar and hood. Upon follow up, the patient was again wearing the same blood soaked shirt and had crusty blood on the staples behind the right ear. The patient stated the incision is not bothering him.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00346 |
| MDR Report Key | 9663196 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2019-11-19 |
| Date Added to Maude | 2020-02-04 |
| 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 | 2020-02-04 |
| Model Number | DB-2202-45 |
| Catalog Number | DB-2202-45 |
| Lot Number | 7070428 |
| 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 | 2020-02-04 |