FDA Adverse Event
Death
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1050956
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01895
- Event Type
- Death
- Date Received
- May 27, 2008
- Date of Event
- March 24, 2006
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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
DIRT IMPLANT, PATIENT WENT TO HOSPITAL WITH COMPLAINT OF DIRTNESS OF BREATH, SEVERE ORTHOPNEA AND BACK MUSCLE PAIN. PATIENT PRESCRIBED ANALGESIC MEDS PRIOR TO GOING HOME. WEEKS AFTER IMPLANT, PATIENT HOSPITALIZED FOR CARDIAC TAMPONADE; SUSPECTED RIGHT VENTRICULAR PERFORATION. LEAD REPOSITIONED 25 DAYS LATER. NEXT DAY BILATERAL PLEURAL EFFUSION SEEN ON X-RAY. DEVELOPED MULTIPLE ORGAN SYSTEM FAILURE AND FAMILY ELECTED DNR STATUS; PT EXPIRED 15 DYS AFTER LEAD REPOSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | NO BNCN FOUND FOR THIS DEVICE | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1590/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Death| H| R |