MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T135

Device Problem No Audible Alarm (1019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2016

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device underwent a thorough evaluation.The device passed the labeled longevity calculation.The device passed all electrical testing.It was confirmed that the device did have beeper functions however the tones were very faint and most likely would not be heard by the patient or physician while implanted.The field allegation was confirmed and no further testing was performed.

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) reached elective replacement indicator (eri), but no beeping was heard.Boston scientific technical services (ts) discussed further on the beeping patterns.The patient was scheduled for device replacement since it had reached elective replacement indicator (eri).This device was explanted for normal battery depletion and was returned back to the laboratory.No adverse patient effects were reported.

• Brand Name: VITALITY
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5788967
• MDR Text Key: 49386662
• Report Number: 2124215-2016-08768
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2009
• Device Model Number: T135
• Other Device ID Number: VITALITY DS VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0185
• Patient Age: 69 YR