FDA Adverse Event
Injury
Summary report: N
XTREL
MDR report key: 2220236
·
Received August 16, 2011
Report
- Report Number
- 3007566237-2011-06446
- Event Type
- Injury
- Date Received
- August 16, 2011
- Report Date
- July 26, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GZF
- PMA / PMN Number
- K904409A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A WHITE SUBSTANCE WAS OBSERVED ON THE EXTERNAL RECEIVED. THE SUBSTANCE WAS BELIEVED TO BE FROM A CORRODED BATTERY. THE NEUROSTIMULATOR WAS BEING EXPLANTED AS PART OF A REPLACEMENT, AND WHEN THE PHYSICIAN MADE AN INCISION THE PT HAD A "MILKY SUBSTANCE INTERNALLY." THE PT WAS GIVEN ANTIBIOTICS AND A SAMPLE OF THE SUBSTANCE WAS SUBMITTED TO A LAB. THE NEW NEUROSTIMULATOR WAS NOT IMPLANTED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | Required Intervention | IMPLANTED:| TRANSMITTER: MODEL 3425, LOT# YU0011155P| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# L33429| EXTENSION: MODEL 7495-51, LOT# XR0022507N| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0009205P |