FDA Adverse Event
Injury
Summary report: N
PROMOTE ACCEL CRT-D, DF-4 CONNECTOR
MDR report key: 3892700
·
Received June 24, 2014
Report
- Report Number
- 2938836-2014-12288
- Event Type
- Injury
- Date Received
- June 24, 2014
- Date of Event
- May 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP, POST-SENSED T WAVE OVERSENSING WAS OBSERVED. THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. PROGRAMMING CHANGES WERE MADE. PATIENT CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369371 | PROMOTE ACCEL CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3215-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |