FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 13657733
·
Received March 3, 2022
Report
- Report Number
- 3006630150-2022-00795
- Event Type
- Injury
- Date Received
- March 3, 2022
- Date of Event
- January 28, 2022
- Report Date
- March 3, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(4), BATCH: 7071285. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7074050.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LEADS WERE TWISTED AS SHOWN BY THE X-RAY DUE TO THE PATIENTS IPG TURNING INSIDE THE POCKET SITE CAUSING TENSION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS TAILS WERE UNRAVELED FROM THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1654714 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 368302 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |