FDA Adverse Event
Injury
Summary report: N
IDENTITY DR
MDR report key: 1073420
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02204
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 10, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- Z2977
- Adverse Event
- 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 DURING A ROUTINE FOLLOW UP THE PULSE GENERATOR WAS OBSERVED TO HAVE NO CAPTURE IN THE RIGHT ATRIUM. THE PHYSICIAN ATTEMPTED INCREASING AMPLITUDE AS WELL AS PULSE WIDTH WITHOUT SUCCESS. THE DEVICE THEN WENT INTO BACKUP VVI MODE. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE, AS IT WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5370 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |