FDA Adverse Event
Injury
Summary report: N
CURRENT ACCEL DR, DF4 CONNECTOR
MDR report key: 3210692
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03376
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 12, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 THE REPORTED FIELD EVENTS OF HIGH HV LEAD IMPEDANCE MEASUREMENTS WERE CONFIRMED VIA REPORT PRINTOUTS. ANALYSIS WAS NORMAL.NO DEVICE ANOMALY WAS FOUND. THE CAUSE OF THE FIELD REPORTED IMPEDANCE ANOMALY COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH OUT OF RANGE HV LEAD IMPEDANCE WAS SEEN DURING PREVIOUS FOLLOW UPS AND AT DEVICE UPGRADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311862 | 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 | Required Intervention | (B)(4) |