FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 10350159
·
Received July 31, 2020
Report
- Report Number
- 3006630150-2020-03182
- Event Type
- Injury
- Date Received
- July 31, 2020
- Date of Event
- January 3, 2020
- Report Date
- July 31, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: 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-2218-50, SERIAL: (B)(4), BATCH: 5077034/5131474.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING PAIN AT THE POCKET SITE DUE TO THE IPG BEING SHALLOW. SYMPTOMS OF SORENESS AROUND THE IPG SITE WAS NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. THE EXPLANTED DEVICES WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 814206 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 361343 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |