FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 10448915
·
Received August 25, 2020
Report
- Report Number
- 3006630150-2020-03629
- Event Type
- Injury
- Date Received
- August 25, 2020
- Date of Event
- July 27, 2020
- Report Date
- August 25, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- 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-2352-50, SERIAL: (B)(4), BATCH: 7070075. PRODUCT FAMILY: SCS-IPG-R, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 369206.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENTS LEAD SITE WAS HOT AND PAINFUL. SYMPTOM OF FLUID DISCHARGED WAS NOTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 913116 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | 5155964 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |