FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1223923
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03382
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 16, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 EXPERIENCED DIZZINESS AND FATIGUE DURING A ROUTINE FOLLOW-UP. THE VENTRICULAR LEAD EXHIBITED VARYING THRESHOLDS. SEQUENTIAL THRESHOLD TESTS SHOWED VALUES RANGING FROM 3.0 V TO 4.5 V WITH A UNIPOLAR IMPEDANCE OF 270 OHMS AND 450 OHMS IN BIPOLAR. THE LEAD WAS CAPPED AND REPLACED.
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 | 1488TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |