FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR
MDR report key: 3901037
·
Received June 30, 2014
Report
- Report Number
- 2938836-2014-12596
- Event Type
- Malfunction
- Date Received
- June 30, 2014
- Date of Event
- May 29, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION NOTES DURING SUBSEQUENT FOLLOW-UP NEW AMS EPISODES WERE PRESENT DUE TO POSSIBLE FAR FIELD ON THE ATRIAL CHANNEL. PROGRAMMING CHANGES WERE MADE. LEAD PROVOCATIVE TESTING AND POCKET MANIPULATION WAS PERFORMED WITH NO NOISE EPISODES. THE PATIENT'S CONDITION IS GOOD AFTER THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP, INAPPROPRIATE AUTO MODE SWITCH EPISODES WERE OBSERVED DUE TO ATRIAL OVERSENSING. ELECTROMAGNETIC INTERFERENCE WAS SUSPECTED. LEAD TESTING AND POCKET MANIPULATION DID NOT REPRODUCE NOISE. PROGRAMMING CHANGES WERE MADE. THE PATIENT MEDICAL CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380101 | QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | CD3371-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |