FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 11002107
·
Received December 14, 2020
Report
- Report Number
- 3006630150-2020-06182
- Event Type
- Injury
- Date Received
- December 14, 2020
- Date of Event
- November 24, 2020
- Report Date
- December 14, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7072511. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: (B)(4), MODEL: SC-1200, SERIAL: (B)(4), BATCH: 371155.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SUTURE WAS LOOPING OUT OF PATIENTS MIDLINE INCISION. THE PATIENT GRABBED THE LOOP AND PULLED ON IT UNTIL IT WAS COMPLETELY EXPOSED. IT WAS NOTED THAT THE LOOP WAS THE PATIENTS RIGHT LEAD. THE PHYSICIAN BELIEVED THAT AN INFECTION WAS PRESENT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PLACED ON ANTIBIOTICS. THE EXPLANTED LINEAR LEADS AND IPG WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1470424 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5117903 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |