FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 15234939
·
Received August 16, 2022
Report
- Report Number
- 3006630150-2022-04081
- Event Type
- Injury
- Date Received
- August 16, 2022
- Date of Event
- March 7, 2022
- Report Date
- August 16, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED AFTER HOSPITALIZATION LAST (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7071190.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENTS STIMULATION WAS LESS EFFECTIVE AND WAS OBTAINING COVERAGE IN THE CHEST WALL AND RIBS DESPITE REPROGRAMMING. LEAD MIGRATION WAS ALSO NOTED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE PLACEMENT OF THE LEADS WERE REVISED AND REMAINED IMPLANTED. THE PATIENT HAD GOOD COVERAGE POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2288356 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5139170 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |