FDA Adverse Event
Injury
Summary report: N
PRECISION MONTAGE MRI
MDR report key: 10198113
·
Received June 25, 2020
Report
- Report Number
- 3006630150-2020-02640
- Event Type
- Injury
- Date Received
- June 25, 2020
- Date of Event
- January 6, 2020
- Report Date
- June 25, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729905943
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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: (B)(4). MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 5132013/5167012.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS POCKET SITE WAS TENDER AND SOME BURNING SENSATION WAS NOTED AT THE LEAD SITE. THE IPG WAS RUBBING ON THE LOWER RIBCAGE AND WAS CAUSING PAIN WITH MOVEMENT. IT WAS ALSO NOTED THAT THE STIMULATION WAS NOT PROVIDING ADEQUATE PAIN RELIEF AND REPROGRAMMING WAS DONE. THE PATIENT HAD BEEN TAKING NORCO FOR THE PAIN AND WAS SCHEDULED FOR A REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 657521 | PRECISION MONTAGE MRI | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1200 | 365549 | 08714729905943 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |