FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1514011
·
Received October 13, 2009
Report
- Report Number
- 2182207-2009-07261
- Event Type
- Injury
- Date Received
- October 13, 2009
- Date of Event
- August 7, 2006
- Report Date
- September 15, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Removal / Correction Number
- Z-0861-06 OR Z-0693-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
BECAUSE THE SERIAL NUMBER OF THE DEVICE UNK, IT'S UNCLEAR IF THE DEVICE WAS PART OF RECALL Z-0861-06 OR Z-0693-2008.
Description of Event or Problem · 1
THE INVESTIGATOR REPORTED "STIMULATOR FAILURE DUE TO DEFECT; 'BROKEN' BANDWIRE PROBLEM". THE STIMULATOR WAS REPLACED. THE EVENT WAS CLASSIFIED AS "MODERATELY SEVERE" AND DEFINITELY RELATED TO THE STIMULATOR. THE EVENT RESOLVED; THE PT HAD A COMPLETE RECOVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC NEUROMODULATION | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL LEADMVD, LOT# UNK| EXTENSION: MODEL EXTENSION, LOT# UNK |