FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 2014116
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01430
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- December 1, 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 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 AT FOLLOW-UP ON (B)(6) 2010 THE RIGHT VENTRICULAR LEAD EXHIBITED IMPEDANCE GREATER THAN 2500 OHMS. WHEN THE LEAD WAS TESTED AGAIN ON (B)(6) 2010, BIPOLAR READINGS WERE OUT OF RANGE AND THERE WAS NO CAPTURE AT 3.5 V. LEAD REPLACEMENT WAS SCHEDULED.
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/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |