INCEPTA

MDR report key: 3912519 · Received July 3, 2014

Report

Report Number: 2124215-2014-13413
Event Type: Malfunction
Date Received: July 3, 2014
Date of Event: May 13, 2014
Report Date: May 28, 2014
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWP
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT TACHYCARDIA THERAPY WAS PROGRAMMED OFF IN THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR AN UNKNOWN REASON. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DETECTED TO HAVE BEEN DEACTIVATED AS PER THE ALERT THAT WAS ISSUED FROM THE PATIENT'S REMOTE MONITORING SYSTEM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION AS TO THE REASON OF THE ICD DEACTIVATION WERE MADE BUT WERE UNSUCCESSFUL. THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389155	INCEPTA	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWP	GUIDANT CRM CLONMEL IRELAND	E162

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR			E162\| 0292\| 4135