FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 16351624
·
Received February 10, 2023
Report
- Report Number
- 3006630150-2023-00530
- Event Type
- Injury
- Date Received
- February 10, 2023
- Date of Event
- August 19, 2022
- Report Date
- February 10, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY#: SCS-IPG-R. UPN#: M365SC8352700. MODEL#: SC-8352-70. SERIAL/LOT#: (B)(4). BATCH #: 7070100.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INADEQUATE STIMULATION AND NOT EXPERIENCING ANY THERAPEUTIC BENEFIT FROM HER SPINAL CORD STIMULATION SYSTEM. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE ENTIRE SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING FINE POST-OPERATIVELY AND EXPECTED TO FULLY RECOVER. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44322 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 365963 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |