FDA Adverse Event
Malfunction
Summary report: N
ENCOR
MDR report key: 1073283
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02082
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 28, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
WHEN THE PATIENT WAS ON VACATION AND EXERCISING, HIS PULSE WAS NOTED TO BE IN THE 30'S. THE ASYMPTOMATIC PATIENT WENT TO THE ER. ECG REVEALED AN ABSENSE OF VENTRICULAR PACING WITH AN INTRINSIC RHYTHM OF APPROXIMATELY 36 BPM. DURING INTERROGATION, LOSS OF OUTPUT COULD NOT BE REPRODUCED. LOSS OF OUTPUT WAS REPRODUCED WHEN THE PATIENT LIFTED HIS LEFT ARM ABOVE HIS HEAD. BIPOLAR LEAD IMPEDANCE GREATER THAN 2500 OHMS WAS NOTED. DEVICE PROGRAMMED TO UNIPOLAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENCOR | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 330-258 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |