KINETRA
Report
- Report Number
- 9614453-2013-01041
- Event Type
- Injury
- Date Received
- May 3, 2013
- Report Date
- April 25, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
(B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT WAS IN THE ICU BECAUSE HE WAS SEPTIC AND INTUBATED. THE SEPSIS WAS NOT BELIEVED TO BE DEVICE RELATED, BUT THE PATIENT HAD ALSO EXPERIENCED A RETURN OF SYMPTOMS. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED SEVERAL FALLS AND THE HCP WAS WORRIED ABOUT A POTENTIAL DISCONNECT OR LEAD BREAKAGE. IT WAS ALSO REPORTED THAT WHEN PERFORMING AN EKG THE HCP DID NOT SEE ANY INTERFERENCE FROM THE DBS SYSTEM, DESPITE THE PROGRAMMER INDICATING THAT THE DEVICE WAS ON ANDWORKING FINE.
ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE SYMPTOMS WERE NOT DEVICE RELATED. THE PATIENT HAD A KIDNEY INFECTION WITH SEVERAL OTHER BACTERIA. A PROGRAMMER WAS FOUND AN A NURSE WAS TALKED THROUGH HOW TO USE IT. IT WAS REPORTED THAT THE PATIENT CONTINUED TO IMPROVE.
IT WAS REPORTED THAT A CLINICIAN PROGRAMMER WAS AVAILABLE TO THE NEUROLOGIST AND UNDER GUIDANCE A SYSTEM CHECK WAS PERFORMED. IT WAS NOTED THAT ALL IMPEDANCES WERE NORMAL AND THERE WAS NO INDICATION THAT THE IMPLANTABLE NEUROSTIMULATOR WAS REACHING END-OF-LIFE (EOL). IT WAS DETERMINED THAT THE CAUSE FOR RETURN OF ¿SYSTEMS¿ WAS DUE TO DISEASE STATE AND COMORBIDITIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194543 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | IPG MFG SWITZERLAND | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |