FDA Adverse Event
Malfunction
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 7150041
·
Received December 27, 2017
Report
- Report Number
- 3006630150-2017-05284
- Event Type
- Malfunction
- Date Received
- December 27, 2017
- Date of Event
- December 5, 2017
- Report Date
- January 25, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- 030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT BELIEVED THAT THE SCS WAS CAUSING A SHOCKING SENSATION IN THE BODY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
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, 56 CM MODEL #: SC-4319 LOT #: 20254596 DESCRIPTION: CLIK X MRI ANCHOR.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THERE WAS A MECHANICAL BREAKDOWN OF THE PATIENTS IPG AND LEADS. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THERE WAS A MECHANICAL BREAKDOWN OF THE PATIENTS IPG AND LEADS. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 927897 | PRECISION MONTAGE MRI | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | NA | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |