FDA Adverse Event
Injury
Summary report: N
MEDTRONIC 6944/65
MDR report key: 3101344
·
Received May 3, 2013
Report
- Report Number
- MW5030088
- Event Type
- Injury
- Date Received
- May 3, 2013
- Date of Event
- April 2, 2013
- Report Date
- May 3, 2013
- Manufacturer
- MEDTRONIC
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EPISODES OF NSVT WERE REVIEWED AND CLEAR NOISE IS SEEN CORRESPONDING TO SHORT V-V INTERVALS. SHORT V-V INTERVALS WERE REPORTED UP TO 1365. LEAD WAS DISABLED AND PATIENT WORE LIFE VEST UNTIL NEW LEAD IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194552 | MEDTRONIC 6944/65 | SPRINT QUATRO | LWS | MEDTRONIC | 6499/65 | MFR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |