FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 1073264
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02063
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- April 1, 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 Location
- NY
- 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)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS ALERTED BY HIS IMPLANT- ABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT THE ATRIAL LEAD IMPEDANCE WAS LESS THAN 100 OHMS. DURING INTERROGATION THE ATRIAL LEAD IMPEDANCE WAS 375 OHMS. THERE WAS NO RECORD OF IMPEDANCE BEING LESS THAN 100 OHMS FOR THIS LEAD. NOISE COULD BE OBSERVED WITH POCKET MANIPULATION. THE SYSTEM WAS LEFT IMPLANTED, AND THE ASYMPTOMATIC PATIENT WOULD BE MONI- TORED CLOSELY.
Description of Event or Problem · 1
NEW INFORMATION NOTES THE LEAD WAS CAPPED DUE TO AN INSULATION ANOMALY ON (B)(6) 2014.
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 | 74 YR | Required Intervention |