FDA Adverse Event
Injury
Summary report: N
ISOFLEX S
MDR report key: 1073051
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-01987
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 16, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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 VENTRICULAR LEAD EXHIBITED LESS THAN 200 OHMS IMPEDANCE IN THE BIPOLAR CONFIGURATION. NOISE WAS PRODUCED WHEN THE PATIENT PERFORMED ISOMETRICS. THE PATIENT REPORTED BEING FATIGUED.
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 | Required Intervention |