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U.S. Department of Health and Human Services

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

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GUIDANT CRM CLONMEL IRELAND ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U128
Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2017
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 the remote home monitoring system issues an alert for high out of range impedance measurements of greater than 2000 ohms for the cardiac resynchronization therapy pacemaker (crt-p) and another manufacturer¿s right atrial (ra) lead where the lead safety switch (lss) was triggered. Review of the data found one higher impedance reading of 1400 ohms from four months earlier. Review of the logbook found inappropriately stored atrial tachy response (atr) episodes from noise due to unipolar configuration after the lss was triggered. Further review found one inappropriate atr due to oversensing of noise from the minute ventilation signal eight months earlier. The field representative noted that the rate response trend had already been programmed off in the crt-p as the patient is pacemaker dependent. Boston scientific technical services (ts) discussed possible causes of abrupt impedance changes. The field representative that she performed maneuvers and could not create noise and all lead measurement were good. Ts discussed the programming options and noted that the other manufacturer¿s rv lead currently is displaying stable impedance measurements. The crt-p and ra lead remain in service and no adverse patient effects were reported. This device was included in the recent mv sensor signal oversensing advisory population.
 
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Brand NameACCOLADE
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 
6515826168
MDR Report Key7979854
MDR Text Key124174960
Report Number2124215-2018-14958
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/26/2018
Device Model NumberU128
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 Received07/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2016
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: 10/18/2018 Patient Sequence Number: 1
Treatment
MISMATCH; U128
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