FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 2102668
·
Received May 23, 2011
Report
- Report Number
- 3004209178-2011-03728
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- January 1, 2011
- Report Date
- April 27, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT STATED THAT HER IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY "IS NOT LASTING A LONG" AS HER FIRST INS. HER HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT HER INS HAD DEPLETED PREMATURELY AND NOTED THIS INS WAS DEPLETING FASTER THAN THE PT'S PREVIOUS INS. THERE WERE NO IMPEDANCE ABNORMALITIES. THE PT DID NOT EXHIBIT ANY SYMPTOMS AND HAD NO INJURY. THE HCP INTENDED TO REPLACE THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT 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 | 45 YR | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU058374V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0455228V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0455228V| EXTENSION: MODEL 7482, LOT# NHU058373V |