FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 19935017
·
Received August 7, 2024
Report
- Report Number
- 3006630150-2024-05182
- Event Type
- Injury
- Date Received
- August 7, 2024
- Date of Event
- July 17, 2022
- Report Date
- August 7, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A COUPLE OF YEARS FROM THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT PRODUCT FAMILY: SCS-LINEAR LEADS, UPN:M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7072109/7072578.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE PAIN RELIEF. ALL DEVICE COMPONENTS WERE REMOVED AND KEPT BY THE MEDICAL FACILITY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2396005 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 370792 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |