FDA Adverse Event
Malfunction
Summary report: N
COVEREDGE 32
MDR report key: 10485340
·
Received September 2, 2020
Report
- Report Number
- 3006630150-2020-03875
- Event Type
- Malfunction
- Date Received
- September 2, 2020
- Date of Event
- August 13, 2020
- Report Date
- September 2, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729832669
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. EXPLANT DATE: (B)(6) 2016. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLELEADS, UPN: M365SC8216500, MODEL: SC-8216-50, SERIAL: (B)(4), BATCH: 17514204.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A FALL AND SUBSEQUENT LEAD FRACTURE. IT WAS NOT CONFIRMED IF THE FALL WAS DEVICE RELATED. THE PHYSICIAN ATTEMPTED TO REVISE THE LEADS BUT WAS UNABLE TO PLACE THEM PROPERLY DUE TO EXCESSIVE SCAR TISSUE FROM PREVIOUS BACK SURGERIES. THE PATIENT UNDERWENT AND EXPLANT PROCEDURE. THE EXPLANTED IPG AND PADDLE LEAD WERE NOT RETURNED. NO FURTHER INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 947250 | COVEREDGE 32 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-8336-50 | 17919969 | 08714729832669 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |