FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1073241
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02045
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- February 4, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- 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
THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYNCOPE. IT WAS REPORTED THAT BOTH LEADS DISLODGED AND NO "SCREW TIP" WAS VISIBLE. REPOSITIONING WAS UNSUCCESSFUL. THE LEADS WERE SUBSEQUENTLY REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1788T/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |