FDA Adverse Event
Injury
Summary report: N
XTREL
MDR report key: 2191002
·
Received July 19, 2011
Report
- Report Number
- 3007566237-2011-05579
- Event Type
- Injury
- Date Received
- July 19, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 24, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GZF
- PMA / PMN Number
- K904409A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LOSS OF THERAPEUTIC EFFECT ALONG WITH SHOCKING AND JOLTING OCCURRED. IT WAS REPORTED THAT NO STIMULATION SENSATION OCCURRED. THE DEVICE SHUT DOWN A COUPLE DAYS AGO. IT WAS REPORTED THAT THE PT WAS STILL HAVING CONCERN REGARDING HIS DEVICE OR THERAPY BUT HAD AN APPOINTMENT WITH THEIR HCP (B)(6)-2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XTREL | GZF/GZB | GZF | MEDTRONIC NEUROMODULATION | 3470 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Male | EXPLANTED:| EXTENSION: MODEL 7495-10, LOT# NAH001841N.| IMPLANTED:| LEAD: MODEL 3487A, LOT#L34942.| LEAD: MODEL 3487A, LOT#L34942| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-10, LOT# NAH001841N |