FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 11861834
·
Received May 21, 2021
Report
- Report Number
- 3006630150-2021-02287
- Event Type
- Injury
- Date Received
- May 21, 2021
- Date of Event
- January 14, 2021
- Report Date
- May 21, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7080635/7080582.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND DISCOMFORT. IT WAS ALSO STATED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760746 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 371320 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |