FDA Adverse Event
Injury
Summary report: N
IDENTITY DR
MDR report key: 1051028
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01335
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- February 19, 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 Location
- NC
- 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 AN ASYMPTOMATIC PATIENT PRESENTED TO A CLINIC WITH HIS DEVICE IN BACKUP VVI MODE. A USER DOWNLOAD DID NOT RESTORE THE DEVICE. AN ERROR MESSAGE WAS DISPLAYED WHEN THE ELECTIVE REPLACEMENT INDICATOR (ERI) BYTE WAS CHECKED. DUE TO CONTINUAL TELEMETRY LOSSES, FURTHER TESTING COULD NOT BE PERFORMED. THE DEVICE WAS REPLACED.
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 |