FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3220299
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04188
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- August 6, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT A NON-SPECIFIC LEAD MALFUNCTION WAS OBSERVED. IT WAS ALSO NOTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED CORRECTIVE SURGERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
NEW INFORMATION NOTES THAT THE LEAD WAS CAPPED AND REPLACED IN (B)(6) 2008 DUE TO NOISE. IN (B)(6) 2013 THE PREVIOUSLY CAPPED LEAD WAS EXPLANTED DURING REVISION OF A SECOND LEAD.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED STATES THAT SUSPECTED LEAD FRACTURE WAS NOTED PRIOR TO LEAD BEING CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319603 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |