FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 14291072
·
Received May 5, 2022
Report
- Report Number
- 3006630150-2022-02050
- Event Type
- Injury
- Date Received
- May 5, 2022
- Date of Event
- March 16, 2022
- Report Date
- May 4, 2022
- 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
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: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 5032341/ 7031332. PRODUCT FAMILY: SCS-EXTENSION; UPN: M365SC3138250; MODEL: SC-3138-25; SERIAL: (B)(4). BATCH: 7011737/ 7011928.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENT BEGAN TO HAVE SPASMODIC MOVEMENTS OF LEGS BUT RESOLVE WHEN DEVICE IS TURN OFF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1463809 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | 204661 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Required Intervention |