FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1073396
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02185
- 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 THE VENTRICULAR THRESHOLD VALUE WAS HIGHER THAN 3.5 V AT 1.5 MS. DURING THE IMPLANT, IT WAS 0.5 V AT 0.5 MS. SWITCHING FROM BIPOLAR TO UNIPOLAR WAS ATTEMPTED BUT THERE WAS NO PACING AT 7.5 V AT 1.5 MS. LEAD IMPEDANCE WAS AROUND 330 OHMS. SINCE THE PATIENT WAS PACEMAKER DEPENDENT, THE PHYSICIAN ELECTED TO REPLACE THE LEAD. WHEN THE SUTURE SLEEVE WAS REMOVED FROM THE LEAD, THE INSULATION WAS FOUND TO BE DAMAGED.
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/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |