FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 2084815
·
Received May 11, 2011
Report
- Report Number
- 2017865-2011-02667
- Event Type
- Injury
- Date Received
- May 11, 2011
- Date of Event
- January 7, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVN
- 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 TWO DAYS POST IMPLANT, ATRIAL CAPTURE THRESHOLDS INCREASED FROM 0.5 V, 0.5 MS TO 4 V, 0.5 MS AND SENSING DECREASED FROM AROUND 3 MV TO 0.1 - 0.2 MV. X-RAY REVEALED DISLODGEMENT OF THE ATRIAL LEAD. THE LEAD WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX S | PERMANENT PACEMAKER ELECTRODE | NVN | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1642T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |