FDA Adverse Event
Malfunction
Summary report: N
CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR
MDR report key: 4973786
·
Received August 5, 2015
Report
- Report Number
- 2938836-2015-28396
- Event Type
- Malfunction
- Date Received
- August 5, 2015
- Date of Event
- June 22, 2015
- Report Date
- June 22, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWS
- PMA / PMN Number
- P030054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT UNDERSENSING WAS OBSERVED DURING A VF EPISODE. THE SENSING WAS SUFFICIENT ENOUGH TO DELIVER A SLIGHTLY DELAYED HV SHOCK WHICH SUCCESSFULLY CONVERTED THE PATIENT. VENTRICULAR SENSITIVITY SETTING WAS DECREASED AND FURTHER PROGRAMMING CHANGES WERE RECOMMENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 516059 | CURRENT+ DR DUAL-CHMBR W/SJ4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | CD2211-36Q | 2876647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |