FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS DR, DF-4 CONNECTOR
MDR report key: 4173900
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16709
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 16, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED PATIENT PRESENTED IN EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO OVERSENSING ON VENTRICULAR CHANNEL. RECOMMENDED PROGRAMMING CHANGES WERE MADE TO DEVICE. NO FURTHER ISSUES WERE REPORTED AFTER CHANGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654021 | CURRENT PLUS DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |