FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 1955834
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00747
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 15, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 VENTRICULAR LEAD EXHIBITED LOSS OF SENSING ON THE VENTRICULAR CHANNEL AND P AND R-WAVES WERE BEING SENSED ON THE ATRIAL CHANNEL. GREATER THAN 2000 OHMS IMPEDANCE AND LOSS OF CAPTURE WERE ALSO OBSERVED. FLUOROSCOPY REVEALED A LEAD FRACTURE NEAR THE PATIENT'S CLAVICLE. AS THE PATIENT WAS NOT PACEMAKER DEPENDENT, THE PHYSICIAN ELECTED TO CHANGE PROGRAMMING TO AAI MODE AND MONITOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX S | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1646T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |