FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER
MDR report key: 15358731
·
Received September 5, 2022
Report
- Report Number
- 3006630150-2022-04541
- Event Type
- Injury
- Date Received
- September 5, 2022
- Date of Event
- June 1, 2019
- Report Date
- September 28, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI; UPN: M365SC8416500; MODEL: SC-8416-50; SERIAL: (B)(6); BATCH: 7011011. PRODUCT FAMILY: SCS-PADDLE LEADS-MRI: UPN: M365SC8416700; MODEL: SC-8416-70; SERIAL: (B)(6); BATCH: 7012091.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE UNKNOWN PATIENT UNDERWENT A DEVICE EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE UNKNOWN PATIENT UNDERWENT A DEVICE EXPLANT PROCEDURE DUE TO UNKNOWN REASON. ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG WAS NONFUNCTIONAL. THE IPG AND PADDLE LEADS WERE EXPLANTED. THE EXPLANTED IPG AND PADDLE LEADS WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2618252 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1160 | 335386 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention |