FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 8352423
·
Received February 19, 2019
Report
- Report Number
- 3006630150-2019-00665
- Event Type
- Injury
- Date Received
- February 19, 2019
- Date of Event
- November 28, 2018
- Report Date
- April 10, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 0
SC-1160 (SN: (B)(4)). DEVICE EVALUATION INDICATED THAT THE IPG PASSED ALL TESTS PERFORMED.
Description of Event or Problem · 0
A REPORT WAS RECEIVED THAT THE PATIENTS WAS EXPERIENCING POST-OP PAIN IN HER LEFT AND GROIN WHICH DESCRIBED AS SHARP AND SHOOTING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-8336-50; SERIAL NUMBER:(B)(4); BATCH/LOT NUMBER: 7002227; MODEL/CATALOG DESCRIPTION: COVEREDGE 32 SURGICAL LEAD KIT 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS WAS EXPERIENCING POST-OP PAIN IN HER LEFT AND GROIN WHICH DESCRIBED AS SHARP AND SHOOTING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145860 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 336505 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |