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U.S. Department of Health and Human Services

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

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GUIDANT CRM CLONMEL IRELAND INGENIO IMPLANTABLE PULSE GENERATOR Back to Search Results
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.
 
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Brand NameINGENIO
Type of DeviceIMPLANTABLE 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 Key6555444
MDR Text Key74773364
Report Number2124215-2017-08125
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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 Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/18/2017
Device Model NumberV273
Other Device ID NumberINTUA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/09/2017 Patient Sequence Number: 1
Treatment
1688TC; H120; MISMATCH; V273
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