FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242981
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06080
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 6, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED NOISE WAS CONFIRMED. ANALYSIS CONFIRMED EXTERNAL INSULATION ABRASION AT 13.6 TO 13.8 CM FROM THE ELECTRODE TIP, CONSISTENT WITH THAT PRODUCED BY FRICTION WITH ANOTHER DEVICE. THIS ABRASION WOULD CAUSE THE REPORTED NOISE. ANOTHER EXTERNAL INSULATION ABRASION WAS ALSO NOTE AT 27.8 TO 28.9 CM FROM THE ELECTRODE TIP. INTERNAL ABRASION WAS FOUND UNDER THE SVC COIL AT 23CM FROM THE CONNECTOR PIN.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
THE PATIENT PRESENTED IN THE HOSPITAL AFTER RECEIVING INAPPROPRIATE SHOCKS FROM NOISE. NOISE WAS NOT REPRODUCIBLE WITH ARM MOVEMENTS BUT WAS OBSERVED DURING INTERROGATION. THE LEAD WAS EXPLANTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED INDICATED LEAD FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |