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 2019-03-29 for PRECISION MONTAGE MRI SC-1200 manufactured by Boston Scientific Neuromodulation.
[140335261]
Concomitant medical products: model number/catalog number: sc-8416-50, serial number: (b)(4), batch/lot number: 7040966, model/catalog description: artisan mri paddle lead 50 cm. The explanted devices were not returned to bsn as they were kept by the medical facility. A review of the manufacturing documentation for the ipg and lead revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[140335262]
A report was received that the patient was experiencing pain after an implant procedure. The patient underwent an explant procedure was doing well postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2019-01411 |
| MDR Report Key | 8465401 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-29 |
| Date of Report | 2019-09-05 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-08-15 |
| Device Manufacturer Date | 2018-10-22 |
| Date Added to Maude | 2019-03-29 |
| 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 CLONMEL LIMITED |
| 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 | PRECISION MONTAGE MRI |
| Generic Name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Product Code | LGW |
| Date Received | 2019-03-29 |
| Model Number | SC-1200 |
| Catalog Number | SC-1200 |
| Lot Number | 358013 |
| 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 | 2019-03-29 |