FDA Adverse Event
Malfunction
Summary report: N
DEFIBRILLATION PATCH LEAD
MDR report key: 3090189
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01266
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- March 5, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- 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 DURING DEVICE CHANGE OUT DUE TO NORMAL ERI, A NOTICEABLE CRACK IN THE OUTER INSULATION OF THE PATCH THAT WAS CONNECTED TO THE RV COIL PORT WAS OBSERVED. THE PATCH WAS CONNECTED TO THE SVC PORT AND THE PATCH ORIGINALLY CONNECTED TO THE SVC PORT WAS CHANGED TO THE RV PORT. THE PATCH REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192057 | DEFIBRILLATION PATCH LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | DP-3238 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |