FDA Adverse Event
Malfunction
Summary report: N
PASSIVE PLUS DX
MDR report key: 1073295
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02094
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- June 26, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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
DURING INTERROGATION, THE LEAD APPEARED TO BE VENTRICULAR OVERSENSING IN BOTH CONFIGURATIONS. THE SENSITIVITY WAS INCREASED FROM 2.0 MV TO 10.0 MV. OVERSENSING WAS OCCASIONALLY MARKED AS R-WAVES, BUT STILL APPEARED ON THE VENTRI- CULAR IEGM. AT PATIENT'S LAST FOLLOW-UP LEAD IMPEDANCE WAS 2009 OHMS AND 1964 OHMS. NOISE HAD NOT INCREASED WITH ISOMETRICS BUT CONTINUES AS BEFORE. THE PATIENT WAS NOT PACEMAKER DEPENDENT.
Description of Event or Problem · 1
THE LEAD WAS CAPPED.
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 | 1336T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |