FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1932049
·
Received November 30, 2010
Report
- Report Number
- 3004209178-2010-10044
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Report Date
- November 18, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- 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
THE PT EXPERIENCED NO ADVERSE REACTIONS WHEN HIS LEAD FRACTURED. THE PT THOUGHT THAT HE FELL, BUT HAS SOME OTHER ISSUES. IT WAS UNCLEAR WHAT EXACTLY HAPPENED. HE WAS SCHEDULED TO HAVE HIS LEAD REPLACED ON (B)(6) 2010. ADD'L INFO HAS BEEN 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 | EXTENSION: MODEL 7482, LOT# NHU067244V| EXTENSION: MODEL 7482, LOT# NHU068091V| PROGRAMMER: MODEL 7436, LOT# NFU009605P| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# J0437510V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# J0428036V |