FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 1073467
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01982
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 DURING A ROUTINE FOLLOW-UP, INTERROGATION REVEALED A RISE IN VENTRICULAR THRESHOLDS AND LEAD IMPEDANCES. OUTPUT WAS SET TO 2.5 V WITH AUTOCAPTURE ON AT THE TIME OF IMPLANT, AND HAD RISEN TO3.5 V. LEAD IMPEDANCE WAS 746 OHMS AT TIME OF IMPLANT, AND HAD RISEN TO 1050 OHMS. THE PATIENT WILL BE MONITORED CLOSELY.
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 |