FDA Adverse Event
Malfunction
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 7678017
·
Received July 11, 2018
Report
- Report Number
- 3006630150-2018-02266
- Event Type
- Malfunction
- Date Received
- July 11, 2018
- Date of Event
- April 15, 2018
- Report Date
- July 9, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2408-56, SERIAL #: (B)(4), DESCRIPTION : AVISTA MRI PERC LEAD KIT, 56CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) WAS NOT WORKING. IT WAS NOTED THAT THE CAUSE OF THE MALFUNCTION COULD NOT BE IDENTIFIED. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 520517 | PRECISION MONTAGE MRI | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | NA | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |