FDA Adverse Event
Malfunction
Summary report: N
BIPOLAR ENDOCARDIAL LEAD
MDR report key: 1050806
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01307
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 12, 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
- PA
- 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 LOSS OF ATRIAL CAPTURE WAS NOTED IN BOTH CONFIGURATIONS AT 7.5 V, 1.5 MS. THE BIPOLAR ATRIAL SENSITIVITY WAS 2.0 MV.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR ENDOCARDIAL LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1242T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |