FDA Adverse Event
Injury
Summary report: N
CURRENT ACCEL DR, DF-4 CONNECTOR
MDR report key: 3872947
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11847
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- April 26, 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 Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING MULTIPLE INAPPROPRIATE HV THERAPIES. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL IN STABLE AND GOOD CONDITION. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349517 | CURRENT ACCEL DR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | CD2215-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7120Q/65, (B)(4) |