FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1997631
·
Received February 16, 2011
Report
- Report Number
- 3004209178-2011-01155
- Event Type
- Malfunction
- Date Received
- February 16, 2011
- Date of Event
- January 1, 2010
- Report Date
- January 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE IMPLANTABLE NEUROSTIMULATOR TURNED ITSELF ON AN OFF DUE TO ELECTROMAGNETIC INTERFERENCE ASSOCIATED WITH USE OF A "NU SKIN GALVANIC SPA". THE HCP WAS NOTIFIED AND PROGRAMMED THE DEVICE OFF. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | LEAD: MODEL 3387, LOT# V003110| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# V003110| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU100162V| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU100164V| EXPLANTED:| PROGRAMMER: MODEL 7436, LOT# NFU012542P| EXPLANTED: |