FDA Adverse Event
Malfunction
Summary report: N
LINEAR ST
MDR report key: 17762468
·
Received September 17, 2023
Report
- Report Number
- 3006630150-2023-05609
- Event Type
- Malfunction
- Date Received
- September 17, 2023
- Date of Event
- August 29, 2023
- Report Date
- September 17, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7130317.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS IMPLANT PROCEDURE WAS ABORTED DUE TO THE PHYSICIANS DIFFICULTY ADVANCING THE LEADS. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE USED LEADS DURING THE PROCEDURE WILL NOT BE RETURNED DUE TO FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302690 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7131384 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Required Intervention |