FDA Adverse Event
Injury
Summary report: N
ISOFLEX P
MDR report key: 1955422
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00768
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 15, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- 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
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED GREATER THAN 2000 OHMS IMPEDANCE. IT WAS NOTED THAT THE PATIENT WAS 81 PERCENT PACED OVER THE LAST YEAR, BUT HAS SINCE BECOME PACEMAKER DEPENDENT WITH NO ESCAPE RHYTHM. THE LEAD WAS CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX P | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1648T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |