FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1926404
·
Received November 11, 2010
Report
- Report Number
- 3004209178-2010-09366
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 27, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING AN UNRELATED MEDICAL PROCEDURE. THE PATIENT WAS IN A CLINIC. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 | 77 YR | IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU155970V| EXPLANTED:| LEAD: MODEL 3387, LOT# V033941| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU155943V| LEAD: MODEL 3387, LOT# V033941| IMPLANTED:| EXPLANTED:| IMPLANTED: |