FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 2973373
·
Received February 21, 2013
Report
- Report Number
- 2938836-2013-00198
- Event Type
- Malfunction
- Date Received
- February 21, 2013
- Date of Event
- January 15, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- 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
DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS NOTED SIGNS OF MELTING ON THE RV AND SVC SHOCK COILS, WHICH MAY INDICATE THAT WHEN THE LEAD DISLODGED AND WAS COILED IN THE HEART THE TWO SHOCK COILS SHORTED TO EACH OTHER DURING HIGH VOLTAGE THERAPY.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A SHOCK AND VIBRATORY ALERT. LOW HVLI AND PLI WAS NOTED WITH A DISPLAY ALERT FOR CIRCUIT DAMAGE. X-RAY REVEALED LEAD DISLODGEMENT. THE LEAD AND ICD WERE EXPLANTED AND REPLACED DUE TO PERSISTENT IMPEDANCE ISSUES. AT CLOSE INSPECTION OF THE LEAD, BURN MARKS WAS NOTED BELOW THE SVC COIL. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76841 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |