FDA Adverse Event
Malfunction
Summary report: N
MATTRIX
MDR report key: 1884862
·
Received October 15, 2010
Report
- Report Number
- 3007566237-2010-08015
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- September 13, 2010
- Report Date
- September 17, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GZF
- PMA / PMN Number
- K934065
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT SLIPPED AND FELL ON HER "BACKSIDE." THE PT WAS NOT USING THE STIMULATION AT THE TIME OF THE FALL. THE PT EXPERIENCED "A LOT" OF PAIN IN THE HIP AND LEGS AND COULD NOT GET OUT OF BED. X-RAYS WERE TAKEN TO CHECK FOR BROKEN BONES, AFTER WHICH THE PT NOTICED A SHOCKING SENSATION IN THE RIGHT LEG AND HIP AT THE IMPLANTABLE NEUROSTIMULATOR LOCATION. THE PT WAS SCHEDULED TO SEE THE HEALTH CARE PROFESSIONAL. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATTRIX | GZF/GZB | GZF | MEDTRONIC NEUROMODULATION | 3272 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | TRANSMITTER: MODEL 3210, LOT # NBU008119P| EXPLANTED:| LEAD: MODEL 3998, LOT # J0406171V| IMPLANTED:| IMPLANTED:| EXPLANDED: |