FDA Adverse Event Malfunction Summary report: N

35 CM BIPOLAR LEAD

MDR report key: 2021326 · Received February 8, 2011

Report

Report Number: 2183787-2011-00017
Event Type: Malfunction
Date Received: February 8, 2011
Report Date: February 9, 2011
Manufacturer: GREATBATCH MED
Product Code: DTB
PMA / PMN Number: K925099
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

RESULTS: REVIEW AND CONFIRMATION OF MFG RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSION: IT CANNOT BE DETERMINED WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, OR PT CONDITION.

Description of Event or Problem · 1

BOSTON SCIENTIFIC REC'D INFO THAT THIS PATIENT'S LEFT VENTRICULAR LEAD WAS EXHIBITING HIGH THRESHOLD MEASUREMENTS OF 7.5V AT 0.4MS. ADDITIONALLY, NO CAPTURE WAS OBSERVED EXCEPT IN TIP TO CAN CONFIGURATION. OUR RECORDS INDICATE THIS LEAD AND THE ASSOCIATED (B)(4) LEAD BOTH ARE ACTIVELY IMPLANTED IN THIS PATIENT'S LEFT VENTRICLE. A CT SCAN WAS PERFORMED TO CONFIRM WHICH LEAD IS THE LEAD IN QUESTION AND IF IT IS STILL ATTACHED TO THE EPICARDIUM. THE RESULTS OF THE SCAN WERE UNK AT THE TIME AND NO OTHER AVERSE EVENTS HAD BEEN REPORTED. ONE MONTH LATER, A PROCEDURE WAS PERFORMED TO REVISE THE LEAD EXHIBITING THE ELEVATED THRESHOLD MEASUREMENTS. SYSTEM EVALUATION REVEALED THIS LEAD TO BE THE (B)(4) LEAD. THIS LEAD WAS SURGICALLY ABANDONED AND EFFORTS TO REPOSITION THE REDUNDANT LEAD (B)(4) WERE UNSUCCESSFUL DUE TO CAPTURE ISSUES. THEREFORE, THIS LEAD WAS ALSO SURGICALLY ABANDONED. THE TWO LEADS WERE IMPLANTED WITHOUT FURTHER INCIDENT. NO ADVERSE PT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	35 CM BIPOLAR LEAD	BIPOLAR LEAD	DTB	GREATBATCH MED	511211	W1424648

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention