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 2020-03-27 for VERCISE CARTESIA DB-2202-30 manufactured by Boston Scientific Neuromodulation.
[186281041]
Additional suspect medical device component involved in the event: brand name: vercise cartesia, upn: (b)(4), model: db-2202-30, serial: (b)(4), batch: 7070031.
Patient Sequence No: 1, Text Type: N, H10
[186281042]
It was reported that three days post implant the patient developed a subcortical hematoma which was moderate in severity. The patient also experienced a seizure which was moderate in severity. The patient was walking and loss consciousness, and an epileptic episode with spasm of the extremity. The patient was admitted into the intensive care unit for observation and given medication. The patient was transferred general floor the following day. It was later noted that the patients regular antiepileptic medication had run out and has not been on medication for days and that this may have also been the source of the seizure. A cat scan was performed which showed 1 to 2 cm hematoma at the right electrode which caused a seizure. A follow up cat scan was done and confirmed that the hematoma resolved. This event was reported as probably related to procedure and not related to the device or stimulation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-01498 |
| MDR Report Key | 9892323 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-10-30 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | DB-2202-30 |
| Catalog Number | DB-2202-30 |
| Lot Number | 7070032 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |