FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 1073310
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02104
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 23, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- 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 VENTRICULAR LEAD EXHIBITED CAPTURE THRESHOLDS OF 6.5 V, 0.6 MS IN THE UNIPOLAR CONFIGURATION. THE PATIENT COULD NOT CAPTURE AT 7.0 V, 0.6 MS IN THE BI- POLAR CONFIGURATION. AN X-RAY DID NOT SHOW ANY EVIDENCE OF LEAD INTEGRITY BEING COMPROMISED. THE PATIENT HAD BEEN FEELING VERY SLEEPY IN THE LAST MONTH. THE LEAD WAS SUB- SEQUENTLY REPLACED.
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 | Required Intervention |