FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA
MDR report key: 20706577
·
Received November 18, 2024
Report
- Report Number
- 3006630150-2024-07941
- Event Type
- Injury
- Date Received
- November 18, 2024
- Date of Event
- October 28, 2024
- Report Date
- November 18, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729821526
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- 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. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 17790843/17736343.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENTS IMPLANTABLE PULSE GENERATOR WILL NO LONGER HOD A CHARGE. IT WAS NOTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD MULTIPLE CONTACTS OUT. THE PATIENT UNDERWENT AN IPG AND SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY AND THE EXPLANTED DEVICE WILL NOT BE RETURN DUE TO FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2620961 | PRECISION SPECTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1132 | 17862854 | 08714729821526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |