FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223605
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03594
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- March 5, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD TWIDDLER'S SYNDROME. IN 2008, PHYSICIAN HAD UNSNARLED THE TWIDDLED LEADS AND PLACED THE DEVICE SUB-PECTORALLY. PATIENT WAS CHECKED POST-OP AND HAD NOT BEEN IN SINCE THAT CHECK-UP UNTIL APPROX FIVE AND A HALF MONTHS LATER. INTERROGATION OF THE DEVICE REVEALED TACHYCARDIA EPISODES DUE TO NOISE ON THE LEADS. PHYSICIAN DECIDED TO CAP BOTH LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |