FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX DR
MDR report key: 1050467
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01448
- 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
- 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
ATTEMPTS TO INTERROGATE THE PULSE GENERATOR WERE UNSUCCESSFUL. MAGNET RATE WAS APPROXIMATELY 90 PPM WITH A-V PACING AT 120 MS. THE MEASURED BATTERY DATA IN JULY 2007 WAS 2.76 V, 11 UA, LESS THAN 1 KOHMS. THE PATIENT HAD TO LEAVE TO GO TO WORK SO A FOLLOW-UP WAS SCHEDULED TO RE-ATTEMPT INTERROGATION.
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 |