FDA Adverse Event
Malfunction
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 7351623
·
Received March 19, 2018
Report
- Report Number
- 3006630150-2018-00887
- Event Type
- Malfunction
- Date Received
- March 19, 2018
- Date of Event
- February 5, 2018
- Report Date
- March 19, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729904816
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2408-56 SERIAL #: (B)(4) DESCRIPTION: AVISTA MRI PERC LEAD KIT, 56 CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATION POTENTIALLY RELATED TO THE EVENT OCCURRED DURING THE MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING HIGH IMPEDANCE ON ONE OF THE LEAD CONTACTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192095 | PRECISION MONTAGE MRI | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2408-56 | NA | 08714729904816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |