FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 2014120
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01413
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- January 19, 2011
- 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
- GA
- 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 NOISE. A DIAPHRAGMATIC STIMULATOR USED TO AID IN THE PATIENT'S BREATHING CAUSED MULTIPLE NOISE REVERSION EPISODES. EGMS AND SURFACE EKG REVEALED NOISE ARTIFACTS EVERY 5-6 SECONDS WHICH COINCIDED WITH THE DIAPHRAGMATIC STIMULATOR FREQUENCY SETTINGS. THE LEAD WILL 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 | 25 YR |