FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 1896654
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04995
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- November 8, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- P960013
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4) - REVIEW OF QUALITY RECORDS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD IMPEDANCE WAS GREATER THAN 2000 OHMS IN THE BOTH THE UNIPOLAR AND BIPOLAR CONFIGURATIONS. LEAD IMPEDANCE INCREASED DRAMATICALLY FROM 510 OHMS TO GREATER THAN 2000 OHMS IN J (B)(6) 2010. THE LEAD EXHIBITED INTERMITTENT CAPTURE. A CHEST X-RAY WAS PLANNED.
Description of Event or Problem · 1
IT WAS ALSO REPORTED THAT THE PATIENT HUNTS WITH A SHOTGUN AND PLACES THE GUN BUTT ON HIS RIGHT SHOULDER WHICH WAS WHERE THE IMPLANT POCKET WAS. THE PULSE GENERATOR WAS MOVED FROM THE LEFT SIDE DUE TO A POCKET INFECTION.
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/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Required Intervention |