FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1180198
·
Received September 29, 2008
Report
- Report Number
- 3004209178-2008-06175
- Event Type
- Injury
- Date Received
- September 29, 2008
- Date of Event
- August 13, 2008
- Report Date
- September 3, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT EXPERIENCED ACUTE HYPOKINESIS AND A SUDDEN WORSENING OF PARKINSON DISEASE SYMPTOMS. HE WAS HOSPITALIZED ABOUT A WEEK LATER WHEN HE WAS NO LONGER ABLE TO WALK OR PERFORM ACTIVITIES OF DAILY LIVING. THE DEEP BRAIN STIMULATOR WAS INTERROGATED AND FOUND TO BE OFF. STIMULATION PARAMETERS WERE CHANGED AND THE PT IMPROVED. THE PT REQUIRED INCREASED MEDICATION DOSAGES. THE GENERATOR BATTERY WAS AT END OF SVC. DEVICE REGISTRATION SYS INDICATES THE DEEP BRAIN STIMULATOR WAS REPLACED. THE HCP/STUDY INVESTIGATOR REPORTED THAT THE ADVERSE EVENT WAS ALSO POSSIBLY RELATED TO PARKINSON MEDICATION THERAPY, PARKINSON DISEASE PROGRESSION, AND A LOW SERUM POTASSIUM (NOT SPECIFIED) AND HEMATOCRIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R | LEAD MODEL 3387 LOT# J0125010V| LEAD MODEL 3387 LOT# J0125010V| SALARTAMINE| IMPLANTED| EXTENSION MODEL 7482 LOT# NHU006107V| VENLAFAXINE| IMPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU006108V| EXPLANTED| SINEMET| ENTACAPONE| CLONAZEPAM| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED |