FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 2073614
·
Received April 27, 2011
Report
- Report Number
- 3004209178-2011-03134
- Event Type
- Injury
- Date Received
- April 27, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 8, 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 THAT THE STIMULATOR WAS "PROTRUDING THROUGH MY CHEST." THE PT'S PHYSICIAN TOLD HIM THE CAUSE WAS DUE TO PROTEIN BUILD-UP UNDER THE DEVICE. SURGERY WAS POSTPONED YESTERDAY BECAUSE STIM WAS INTERFERING WITH EKG READINGS. ADDITIONAL INFORMATION WAS REQUESTED.
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 | 76 YR | Other | IMPLANTED:| PROGRAMMER: MODEL 7436, LOT # NFU017687P| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT # NHU131140V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT # NHU131142V| UNKNOWN MODEL: 3387S-40, LOT # V006878| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| UNKNOWN MODEL 3387S-40, LOT # V006878| EXPLANTED: |