FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1223839
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03443
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 4, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- 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
IT WAS REPORTED THAT THE LEAD EXHIBITED REPRODUCIBLE NOISE. THE NOISE WAS FIRST NOTED IN 2005. THE LEAD WAS REPLACED DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACEMENT.
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 | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |