FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX DR
MDR report key: 1050443
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01424
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- March 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- TX
- 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 THE PULSE GENERATOR COULD NOT BE INTERROGATED. ATTEMPTS AT VERIFYING THE ID AND ELECTIVE REPLACEMENT INDICATOR BYTES WERE UNSUCCESSFUL DUE TO THE INABILITY TO MAINTAIN TELEMETRY. THE SURFACE ECG REVEALED A PATIENT INTRINSIC RHYTHM OF SINUS BRADYCARDIA AT APPROXIMATELY 50 BPM. THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND WAS HOSPITALIZED WITH LIMITED HISTORY AVAILABLE. THE PATIENT ELECTED NOT TO HAVE THE DEVICE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5380 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |