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 2019-11-29 for SPECTRA WAVEWRITER SC-1160 manufactured by Boston Scientific Neuromodulation.
[168468018]
The exact date of the event is unknown. The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event. Explant date: (b)(6) 2019. Model number/catalog number: sc-2317-70, serial number: (b)(4), batch/lot number: 5070272/7054504, model/catalog description: infinion cx lead kit, 70 cm. The explanted devices were not returned to bsn. A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing. A review of the sterilization documentation for the devices was found to be satisfactory.
Patient Sequence No: 1, Text Type: N, H10
[168468019]
A report was received that the patient had contracted a serious infection. The patient underwent an explant procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006630150-2019-06947 |
| MDR Report Key | 9391996 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-11-11 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2019-11-29 |
| 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 CORPORATION |
| 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 | SPECTRA WAVEWRITER |
| Generic Name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Product Code | LGW |
| Date Received | 2019-11-29 |
| Model Number | SC-1160 |
| Catalog Number | SC-1160 |
| Lot Number | 355970 |
| 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 | 2019-11-29 |