FDA Adverse Event
Death
Summary report: N
KINETRA
MDR report key: 1801370
·
Received August 12, 2010
Report
- Report Number
- 3004209178-2010-06073
- Event Type
- Death
- Date Received
- August 12, 2010
- Date of Event
- June 19, 2007
- Report Date
- July 16, 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
- NM, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REFER TO MFR REPORT # 6000153-2007-01961 FOR ANALYSIS OF AN EXPLANTED LEAD ((B)(4)).
Description of Event or Problem · 1
AN ATTORNEY ALLEGED THAT A PT DEATH HAD OCCURRED. THE CLAIM WAS THAT THE IMPLANTED DEVICES (LEADS) WERE ALLEGEDLY DEFECTIVE. REFER TO MFR REPORT #'S 6000153-2007-01960 AND 6000153-2007-01961.
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 | 50 YR | Death | IMPLANTD:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0454848V| EXPLANTED:| LEAD: MODEL 3387, LOT # J0519210V| LEAD: MODEL 3387S, LOT # V025975| EXPLANTED:| EXPLANTED:| IMPLANTED: |