FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1617633
·
Received February 16, 2010
Report
- Report Number
- 3004209178-2010-01119
- Event Type
- Injury
- Date Received
- February 16, 2010
- Report Date
- January 21, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009/S27
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT STARTING TWO DAYS BEFORE. IT WAS STATED THAT THE WIRES PULLED WHEN THE PT MOVED HIS NECK; HE HAD DECREASED RANGE OF MOTION. PUSHING UP ON THE INS TOWARDS THE COLLAR BONE RELIEVED THE TIGHTNESS OF THE WIRES. IT WAS BELIEVED THAT IF THE INS WAS MOVED UP 1/2 INCH THEN IT WOULD RELEASE THE TENSION. WHEN THE PT TURNED HIS HEAD HE SAW THE WIRES IN HIS CHEST. IT WAS FURTHER STATED THAT THE PT WAS GETTING THE RELIEF HE NEEDED BUT THE LEADS WERE INTERFERING WITH HIS HEAD MOVEMENT; HE COULD FEEL THEM PULL. THE EXTENSIONS WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V238014| EXTENSION: MODEL 7482A, LOT# NHU197137V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V238014| EXTENSION: MODEL 7482A, LOT# NHU197138V| EXPLANTED:| EXPLANTED: |