FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 2013865
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01402
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 2, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 THE PATIENT DEVELOPED HICCUPS POST IMPLANT. WHEN THE DEVICE WAS INTERROGATED, LOSS OF ATRIAL SENSING AND CAPTURE WERE OBSERVED. PROGRAMMING WAS SWITCHED TO VVI, AND THE HICCUPS STOPPED. THE ATRIAL LEAD WAS SUCCESSFULLY REPOSITIONED ON (B)(6) 2010.
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 | 1642T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |