FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2212654
·
Received August 11, 2011
Report
- Report Number
- 3004209178-2011-06283
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- July 7, 2011
- Report Date
- July 18, 2011
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PRODUCT WAS EXPLANTED AFTER THE BATTERY DRAINED DUE TO A SUSPECTED SHORT. THE PATIENT WAS NOT RECEIVING THERAPEUTIC EFFECT. THE INTERNAL PULSE GENERATOR AND 2X4 CONNECTOR WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.
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 | 60 YR | Required Intervention | EXTENSION: MODEL 7482, LOT # NHU114849V| LEAD: MODEL 3387, LOT # V002272| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT # NJZ101119N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT # NHU114848V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # V002272| EXPLANTED: |