FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 18454468
·
Received January 5, 2024
Report
- Report Number
- 3006630150-2023-08449
- Event Type
- Injury
- Date Received
- January 5, 2024
- Date of Event
- March 7, 2021
- Report Date
- January 5, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. D6B: EXPLANT DATE: PROCEDURE HAPPENED TWO MONTHS AFTER IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7073503 / 7072600.
Description of Event or Problem · 0
IT WAS REPORTED THAT FOLLOWING TRIAL PROCEDURE THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION AT THE LEAD INCISION SITE. SYMPTOM OF PUS WAS NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE RELATED. THE PATIENT PRESCRIBED ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674844 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 375714 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female | Required Intervention |