FDA Adverse Event Malfunction Summary report: N

INCEPTA

MDR report key: 2911397 · Received January 11, 2013

Report

Report Number: 2124215-2012-15948
Event Type: Malfunction
Date Received: January 11, 2013
Date of Event: November 26, 2012
Report Date: November 28, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A TECHNICAL SERVICES CONSULTANT REVIEWED THE EPISODE AND DETERMINED THAT PACING WAS INHIBITED FOR GREATER THAN TWO SECONDS DUE TO THE OVERSENSED NOISE. THE LEAD AND DEVICE REMAIN IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Additional Manufacturer Narrative · 1

BOSTON SCIENTIFIC RECEIVED NEW INFORMATION THAT THE PATIENT WAS BROUGHT IN TO TROUBLESHOOT THE CAUSE OF THE NOISE AND OVERSENSING. IT WAS NOTED THAT THIS PATIENT WAS PACEMAKER DEPENDENT, AND THE PATIENT'S HEART CONDITION RESULTED IN NO INDUCTION TESTING AT THE IMPLANT PROCEDURE. SPECIFIC PATIENT MANEUVERS WERE PERFORMED AT VARIOUS SENSITIVITY SETTINGS; THE ORIGIN OF THE NOISE WAS DETERMINED TO BE ABDOMINAL IN NATURE. THE SENSITIVITY SETTING WAS THEN REPROGRAMMED TO 0.3MV, AS THIS PROVIDED THE BEST RESULT FOR PREVENTING THE OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE DEVICE CHECK, ONE NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODE WAS STORED, DUE TO NOISE THAT WAS OVERSENSED. A REVIEW OF THE ELECTROGRAMS CONFIRMED THE NOISE. NO CHANGES WERE MADE TO THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
17366	INCEPTA	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	P162

Patients

Seq	Age	Sex	Outcome	Treatment
1