FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 12764060
·
Received November 7, 2021
Report
- Report Number
- 3006630150-2021-06282
- Event Type
- Injury
- Date Received
- November 7, 2021
- Date of Event
- May 24, 2021
- Report Date
- November 7, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5091808/5097094.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. IT WAS NOTED THAT THE IPG HAD TILTED AND WAS AT THE END OF LIFE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG WAS MOVED AND THE ANCHORS WERE TUNNELED INTO THE NEW IPG SITE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1658307 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 21118438 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention |