SPECTRA WAVEWRITER?
Report
- Report Number
- 3006630150-2025-05087
- Event Type
- Injury
- Date Received
- July 2, 2025
- Date of Event
- June 14, 2025
- Report Date
- January 19, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CORRECTION TO THE SUPPLEMENTAL MDR IN H6. B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8216500. MODEL: SC-8216-50. SERIAL: (B)(6). BATCH: 7071068. UDI: (B)(4).
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7071068, UDI: (B)(4).
B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(6), BATCH: 7071068, UDI: (B)(4).
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THESE SCS DEVICES WERE EXPLANTED DUE TO A SUSPECTED INFECTION. CULTURE SAMPLES WERE COLLECTED FOR MICROBIOLOGICAL ANALYSIS AND RETURNED NEGATIVE, INDICATING NO EVIDENCE OF INFECTION. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD REVISION PROCEDURE WHEREIN THEIR IPG AND LEAD WERE EXPLANTED. THE DEVICES WILL NOT RETURN FOR ANALYSIS DUE TO HOSPITAL POLICY. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY, REPORTING SATISFACTION WITH THE REMOVAL.
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THESE SPINAL CORD STIMULATION (SCS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATES THAT THESE SCS DEVICES WERE EXPLANTED DUE TO A SUSPECTED INFECTION. CULTURE SAMPLES WERE COLLECTED FOR MICROBIOLOGICAL ANALYSIS AND RETURNED NEGATIVE, INDICATING NO EVIDENCE OF INFECTION. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD REVISION PROCEDURE WHEREIN THEIR IPG AND LEAD WERE EXPLANTED. THE DEVICES WILL NOT RETURN FOR ANALYSIS DUE TO HOSPITAL POLICY. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY, REPORTING SATISFACTION WITH THE REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1200616 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 370677 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Required Intervention |