FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 1050462
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01443
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- January 25, 2008
- 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
- FL
- 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 DURING A TRANSTELEPHONIC MONITORING CHECK, THE LEAD EXHIBITED INTERMITTENT VENTRICULAR SENSING. THE MAGNET BEHAVIOR WAS APPROPRIATE. THE LEAD TESTED WELL IN AN OFFICE VISIT. THE PATIENT WOULD BE MONITORED.
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 |