FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1083098
·
Received July 24, 2008
Report
- Report Number
- 3004209178-2008-04346
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 18, 2008
- Report Date
- June 24, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD A LEAD REVISION DUE TO ABNORMAL IMPEDANCES AND A LEAD BREAKAGE. NO SYMPTOMS WERE REPORTED. THE PATIENT RECOVERED WITHOUT SEQUELA.
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 | Required Intervention | EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU101022V| EXPLANTED:| IMPLANTED:| EXPLATNED:| PROGRAMMER MODEL PROGRAMMER LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD MODEL 3387S LOT# V063294| LEAD MODEL 3387S LOT# V011797| IMPLANTED:| LEAD MODEL 3387S LOT# V011075| EXTENSION MODEL 7482 LOT# NHU101021V| IMPLANTED: |