FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE-FIXATION LEAD
MDR report key: 758333
·
Received September 5, 2006
Report
- Report Number
- 2938836-2006-00658
- Event Type
- Injury
- Date Received
- September 5, 2006
- Date of Event
- August 4, 2006
- Report Date
- August 4, 2006
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IN ITS ENTIRETY WAS COMPLETED SOLELY BY MEDICAL, INC., CRMD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD REQUIRED REPOSITIONING DUE TO AN IMPEDANCE MEASUREMENT ANOMALY. DURING REPOSITIONING, THE HELIX WOULD NOT RE-EXTEND AND THEREFORE THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE-FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |