FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3231321
·
Received July 17, 2013
Report
- Report Number
- 3007566237-2013-02373
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Report Date
- November 4, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REACHING THE END OF ITS LIFE CYCLE AND IT WAS ABOUT NINE YEARS OLD. THE DEVICE WAS IMPLANTED ABOVE THE RIBCAGE ON THE LEFT SIDE OF THE PATIENT¿S BODY. THE LOCATION OF THE IMPLANTABLE NEUROSTIMULATOR SEEMED TO HAVE SHIFTED, AND IN ITS CURRENT LOCATION WAS CAUSING DISCOMFORT. THE DISCOMFORT CAME IN THE FORM OF AN INTERMITTENT SHARP PAIN LOCALIZED TO WHERE THE IMPLANTABLE NEUROSTIMULATOR WAS. THIS FIRST BECAME AN ISSUE WHEN THE PATIENT WAS RESTRAINED IN A PHYSICAL ALTERCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330773 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR |