FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 1830672
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03339
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 13, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO DOUBLE COUNTING ON T-WAVE. THE DEVICE WAS REPROGRAMMED. ON (B)(6) 2010 AN INDUCTION TEST WAS PERFORMED BUT MANY R-WAVES WERE NOT SENSED. THE PHYSICIAN HAS NOT DECIDED YET WHETHER TO REPLACE THE LEAD.
Description of Event or Problem · 1
THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7002/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |