MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE PULSE GENERATOR

Model Number V273

Device Problems Premature Discharge of Battery (1057); Device Operates Differently Than Expected (2913)

Patient Problem Atrial Fibrillation (1729)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) had ten years longevity two years ago and now battery showed six years longevity.Additional information was obtained from field representative indicating that the initial value was a projection when longevity calculation was not yet done.The patient was put on transtelephonic monitoring (ttm), and on following check up, device showed 6.5 years longevity.This was due to some factors such as; patient had atrial fibrillation (af) which caused high rate sensing that led to high power consumption, high left ventricular (lv) lead output and lower rate limit (lrl) of 80 beats per minute (bpm).No adverse patient effects were reported.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6555444
• MDR Text Key: 74773364
• Report Number: 2124215-2017-08125
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526536670
• UDI-Public: (01)00802526536670(17)20170318
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/18/2017
• Device Model Number: V273
• Other Device ID Number: INTUA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• 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: 1688TC; H120; MISMATCH; V273
• Patient Age: 85 YR