FDA Adverse Event
Injury
Summary report: N
PASSIVE PLUS DX
MDR report key: 2013971
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01343
- Event Type
- Injury
- Date Received
- March 10, 2011
- Date of Event
- December 21, 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
- WA
- 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
NEW INFORMATION NOTES THE LEAD WAS ALSO FRACTURED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PACEMAKER DEPENDENT PATIENT PRESENTED IN THE EMERGENCY ROOM DUE TO A SYNCOPAL EPISODE. THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE, CAUSING A FIVE SECOND PAUSE. THE LEAD WAS CAPPED AND 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/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |