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 2020-01-16 for VERCISE CARTESIA DB-2202-45 manufactured by Boston Scientific Neuromodulation.
[175448394]
(b)(6). It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device cannot be completed. A review of the device history records will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[175448395]
It was reported that a patient implanted with a db-2202-45 experience mild left peri-lead edema that was assessed by the physician to be mild in severity. Device was reprogrammed and the patient was treated with medication. It was reported that the event is resolving; and that the physician assessed this event to have a causal relationship to the procedure, unlikely related to stimulation, and not related to device hardware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2020-00079 |
| MDR Report Key | 9599281 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-16 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-10-23 |
| Date Added to Maude | 2020-01-16 |
| 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 | 2020-01-16 |
| Model Number | DB-2202-45 |
| Catalog Number | DB-2202-45 |
| Lot Number | 5180069 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-16 |