FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA 16
MDR report key: 19945846
·
Received August 8, 2024
Report
- Report Number
- 3006630150-2024-05217
- Event Type
- Injury
- Date Received
- August 8, 2024
- Date of Event
- May 10, 2024
- Report Date
- August 8, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED MONTHS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(6), BATCH: 7071532.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY. NO DEVICE MALFUNCTION WAS SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1635204 | WAVEWRITER ALPHA 16 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1216 | 507934 | 08714729985082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |