FDA Adverse Event
Injury
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 4221057
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17419
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- September 11, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
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 PRESENTED VIA MERLIN DUE TO HIGH VOLTAGE LEAD IMPEDANCE. LOSS OF SENSING WAS ALSO NOTICED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER ISSUES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703085 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7040/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |