FDA Adverse Event
Malfunction
Summary report: N
QUADRA ASSURA CRT-D, DF4 CONNECTOR
MDR report key: 3101267
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-02073
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- March 13, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT PRESENTED IN CLINIC AFTER EXPERIENCING DIAPHRAGMATIC STIMULATION. CLINICIAN WAS ABLE TO REPRODUCE THE STIMULATION. PROGRAMMING OPTIONS AND CONFIGURATIONS WERE RECOMMENDED TO RESOLVE THE ISSUE, BUT THE CLINICIAN DID NOT WANT TO DO FURTHER TESTING. THE PATIENT WOULD BE FOLLOWED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203237 | QUADRA ASSURA CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3267-40Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |