FDA Adverse Event
Malfunction
Summary report: N
PASSIVE PLUS DX
MDR report key: 1896580
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04885
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 22, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Removal / Correction Number
- NA
- 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 IN (B)(6) 2010 THE LEAD IMPEDANCE WAS 1400 OHMS. ONE MONTH LATER THE IMPEDANCE HAD INCREASED TO GREATER THAN 2000 OHMS IN THE BIPOLAR CONFIGURATION. THE LEAD WAS PROGRAMMED TO THE UNIPOLAR CONFIGURATION AND REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PASSIVE PLUS DX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1346T/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |