FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS VR, DF-4 CONNECTOR
MDR report key: 4153510
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16440
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 9, 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
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING INAPPROPRIATE ATP AND HIGH VOLTAGE THERAPIES. PROGRAMMING CHANGES WERE RECOMMENDED. HOWEVER, THE DECISION WAS MADE TO CHANGE THE PATIENTS MEDICATION INSTEAD. THE PATIENT WILL BE MONITORED WITH ROUTINE FOLLOW UPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632074 | CURRENT PLUS VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD1211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |