FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1073397
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02186
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 6, 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
IT WAS REPORTED THAT ONE DAY POST IMPLANT ATRIAL LEAD IMPEDANCE WAS LESS THAN 200 OHMS. THE PHYSICIAN OPENED THE POCKET TO CHECK THE CONNECTIONS, AND FOUND IMPEDANCE TO BE 3500 OHMS ON THE PACING SYSTEM ANALYZER (PSA), SO HE DECIDED TO REPLACE THE LEAD.
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 | 1788TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |