FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 1051034
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01343
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 PATIENT WENT TO THE EMERGENCY ROOM BECAUSE THE PATIENT NOTIFIER WAS ACTIVATED. THE DEVICE WAS INTERROGATED AND AN ALERT APPEARED INDICATING THAT THERE WAS LESS THAN 100 OHMS ATRIAL LEAD IMPEDANCE. TESTS WERE REPEATED AND APPROXIMATE VALUES OF 450 OHMS WERE CONSISTENT. ISOMETRIC AND POSITIONAL TESTING DID NOT REVEAL ANY NOISE. THE SYSTEM REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1688T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |