FDA Adverse Event
Malfunction
Summary report: N
PASSIVE PLUS DX
MDR report key: 3925848
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15677
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- April 18, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS PRESENTED IN CLINIC FOR A ROUTINE DEVICE CHECK. UPON AN AUTOCAPTURE SETUP TEST, THE PATIENT EXPERIENCED SYNCOPAL EPISODES DUE TO LOSS OF VENTRICULAR CAPTURE OF BACKUP PULSE. IT WAS DISCOVERED THAT THE BIPOLAR VENTRICULAR LEAD HAD FRACTURED AT THE BIPOLAR PORTION. THE LEAD WAS REPROGRAMMED. THE LEAD REMAINED IMPLANTED AND THE PATIENT HAD NO FURTHER SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404157 | PASSIVE PLUS DX | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1346T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR |