FDA Adverse Event
Malfunction
Summary report: N
CURRENT ACCEL DR, DF4 CONNECTOR
MDR report key: 3210663
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03378
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 1, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- 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 THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING AN ALERT DUE TO HIGH VOLTAGE LEAD IMPEDANCE OUT OF RANGE. THE IMPEDANCE MEASUREMENTS IN CLINIC WERE NORMAL AND NO RECENT DATA SUPPORTED THE LOW MEASUREMENTS. AFTER REVIEWING THE RECORDS, IT WAS DETERMINED TO BE A DIAGNOSTIC ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309702 | CURRENT ACCEL DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2215-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |