FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 1073399
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02188
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- December 19, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 AT IMPLANT, IT WAS DIFFICULT TO INSERT THE ATRIAL LEAD INTO THE ATRIAL PORT OF THE PULSE GENERATOR. TWO DAYS POST IMPLANT, IMPEDANCE REACHED OVER 2500 OHM. THE PHYSICIAN REPOSITIONED THE LEAD, AFTER WHICH IMPEDANCE WAS 487 OHM. FIVE DAYS LATER, IMPEDANCE HAD DECREASED TO 285 OHM AND THE DEVICE WAS FOUND TO BE WORKING INTERMITTENTLY. THE SYSTEM WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5376 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |