FDA Adverse Event
Malfunction
Summary report: N
FAST-PASS ACE
MDR report key: 3920765
·
Received July 8, 2014
Report
- Report Number
- 2017865-2014-14355
- Event Type
- Malfunction
- Date Received
- July 8, 2014
- Date of Event
- August 30, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 ATRIAL LEAD EXHIBITED OVERSENSING CAUSING INHIBITION. THE DEVICE WAS REPROGRAMMED TO DECREASE ATRIAL SENSITIVITY ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396097 | FAST-PASS ACE | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC., CRMD | 1013M/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |