FDA Adverse Event
Injury
Summary report: N
CURRENT ACCEL VR, DF-4 CONNECTOR
MDR report key: 3210693
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03377
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 27, 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
THE REPORTED FIELD EVENT OF NOISE WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND MET ALL TEST SPECIFICATIONS. NO NOISE WAS OBSERVED DURING TESTING AND NO STORED ELECTROGRAMS WERE AVAILABLE FOR REVIEW.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED. THE NOISE CAUSED INHIBITION OF VENTRICULAR PACING, WHICH CAUSED THE PATIENT TO EXPERIENCE SYNCOPE. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309704 | CURRENT ACCEL VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2215-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | (B)(4) |