FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 8203983
·
Received December 28, 2018
Report
- Report Number
- 3006630150-2018-62529
- Event Type
- Injury
- Date Received
- December 28, 2018
- Date of Event
- December 10, 2018
- Report Date
- December 28, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-4318, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 21911483 / 22296791, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT. MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5030903, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS NOT GETTING ADEQUATE STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE TWO CLICK ANCHORS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1041749 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70 | 5000605 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |