FDA Adverse Event Injury Summary report: N

TENDRIL ST

MDR report key: 1050605 · Received May 27, 2008

Report

Report Number: 2017865-2008-01572
Event Type: Injury
Date Received: May 27, 2008
Date of Event: March 19, 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: TN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

FINAL ANALYSIS FOUND AN INTERMITTENT SHORT CIRCUIT BETWEEN THE COILS DUE TO A DAMAGED INNER INSULATION. BOTH INSULATIONS WERE DAMAGED DUE TO SUBCLAVIAN CRUSH AT 24.8 CM FROM THE CONNECTOR PIN. FDA REQUEST FOR ADDITIONAL INFORMATION: A REQUEST FOR ADDITIONAL INFORMATION: THE FINAL RESULTS OF ANY FAILURE ANALYSIS OR LABORATORY TESTING OF THE DEVICE LISTED IN THE REPORT(S) INCLUDING: A COMPLETE DESCRIPTION OF THE METHODOLOGY(IES) USED, AN IDENTIFICATION OF THE FAILURE MODE(S)/OR MECHANISM(S) AND THE ASSOCIATED COMPONENT(S) INVOLVED, ANY CONCLUSIONS BASED ON THE FINAL FAILURE ANALYSIS OR LABORATORY TEST RESULTS. ST. JUDE MECIAL RESPONSE: RESULTS AND CONCLUSION: CONTAINED IN THIS REPORT.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SYNCOPE. THE NEXT DAY, THE DEVICE EXHIBITED PAUSES IN RHYTHM, BUT ONLY WHEN THE PATIENT USED THE LAVATORY. WHILE AT HOME, THE PATIENT EXPERIENCED TWO MORE ASYSTOLIC EPISODES. OVERSENSING WAS SUSPECTED. THE PATIENT WAS PACEMAKER DEPENDENT.

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	1888TC/58	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention