FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2052519
·
Received April 11, 2011
Report
- Report Number
- 3004209178-2011-02735
- Event Type
- Injury
- Date Received
- April 11, 2011
- Date of Event
- January 1, 2009
- Report Date
- March 23, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED 2 YEARS AGO, THE PT'S STIMULATOR WAS REPLACED DUE TO BATTERY DEPLETION AND SINCE THEN THE PT HAS HAD SEIZURES. THE REPORTER BELIEVED THE SEIZURES WERE HEREDITARY SINCE THE PT'S BROTHER ALSO HAD SEIZURES. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL 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 | 33 YR | Other | LEAD: MODEL 3387, LOT# V005847| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU106837V| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU119515V| EXPLANTED:| LEAD: MODEL 3387, LOT# J0555451V| EXPLANTED:| EXPLANTED: |