FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR
MDR report key: 3781886
·
Received April 30, 2014
Report
- Report Number
- 2938836-2014-10112
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- March 28, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT DECREASED R-WAVES WERE OBSERVED VIA REMOTE TRANSMISSION.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2016. PATIENT CONDITION WAS GOOD.
Description of Event or Problem · 1
IT WAS REPORTED DURING INTERROGATION, ONE VF EPISODE WAS OBSERVED, AND THE ARRHYTHMIA STOPPED BEFORE THE THERAPY WAS DELIVERED. DURING THE ARRHYTHMIA, OVERSENSING AND UNDERSENSING WERE OBSERVED. NO ACTION WAS TAKEN AT THIS TIME AND THE PATIENT IS IN GOOD MEDICAL CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259187 | DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7170Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |