FDA Adverse Event
Injury
Summary report: N
PROMOTE RF
MDR report key: 1223113
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03747
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 26, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED LOW IMPEDANCE ONE DAY POST IMPLANT. THE DEVICE HAD SHIFTED WITHIN THE POCKET, AND WAS NEAR ONE OF THE LEADS, WHICH COULD CAUSE THE HV LEAD IMPEDANCE TO BE OUT OF RANGE. THE POCKET WAS OPENED, AND THE LEAD WAS MOVED AWAY FROM THE ICD CAN. THIS SUCCESSFULLY BROUGHT THE HV LEAD IMPEDANCE MEASUREMENTS WITHIN NORMAL RANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE RF | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 3207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |