FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 12530723
·
Received September 25, 2021
Report
- Report Number
- 3006630150-2021-05395
- Event Type
- Injury
- Date Received
- September 25, 2021
- Date of Event
- June 3, 2021
- Report Date
- September 25, 2021
- 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
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEAD, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5162770.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING DISCOMFORT ON THE LEFT SIDE OF THE BACK, TORSO AND RIBS AND WAS FEELING PRESSURE ON THE RECTUM WITH DIFFICULTY PASSING A BOWEL MOVEMENT POST LEAD REVISION PROCEDURE (MFR. REPORT NUMBER: 3006630150-2021-03124). THE X RAY REVEALED THAT THE LEFT LEAD HAD MIGRATED CADUALLY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ONLY THE LEFT LEAD WAS REMOVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND EXPLANTED LEAD WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1428375 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7091913 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |