FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 10311761
·
Received July 22, 2020
Report
- Report Number
- 3006630150-2020-03045
- Event Type
- Injury
- Date Received
- July 22, 2020
- Date of Event
- July 7, 2020
- Report Date
- July 22, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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: 7073132.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE AFTER THE LEADS WERE IMPLANTED AND ANCHORED, THE PATIENT CODED. THE PATIENT WAS FLIPPED TO STABILIZED VITALS, INTUBATED, THEN PREPPED AND DRAPED. THE PHYSICIAN TRIED TO STERILIZED THE LEADS AND TUNNELED AND CLOSED. THE PATIENT HAS BEEN SEEN BY THE PHYSICIAN SEVERAL TIMES SINCE THE EVENT AND IS DOING WELL POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773807 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5171825 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |