FDA Adverse Event
Injury
Summary report: N
PASSIVE PLUS DX
MDR report key: 2013972
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01345
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 7, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH
- 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
AFTER A BUS ACCIDENT THE RIGHT VENTRICULAR LEAD EXHIBITED A HIGH CAPTURE THRESHOLD OF GREATER THAN 4 V AND LOW IMPEDANCE FROM LESS THAN 200 OHMS TO A MAXIMUM OF 333 OHMS IN BOTH CONFIGURATIONS. DIAGNOSTICS SHOWED LESS THAN ONE PERCENT PACING IN THE VENTRICLES. WHEN CAPPING THE LEAD, AN INSULA-TION BREECH WAS OBSERVED. THE LEAD WAS REPLACED.
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 | 49 YR | Required Intervention |