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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 U125
Device Problems Failure to Capture (1081); Low impedance (2285); Ambient Noise Problem (2877); Capturing Problem (2891)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2017
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 left ventricular (lv) threshold was 4v, so the health care provider reprogrammed this cardiac resynchronization therapy pacemaker (crt-p) to a different vector to reduce thresholds. However, this resulted in low pacing impedances. There was then a lead safety switch (lss) due to pacing impedance less than 200 ohms, which resulted in an automatic change in lead configuration. The health care provider reported that the non-boston scientific lv lead was not capturing after the lss. The patient was brought into the clinic for evaluation. During evaluation, it was noted that lv pacing impedance had been occasionally out of range for the last several months. There was also noise observed on both the left and right ventricular channels. No adverse patient effects were reported. The crt-p and non-bsc lv lead remain in service. No interventions reported.
 
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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 Key7977288
MDR Text Key124092508
Report Number2124215-2018-15751
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 07/05/2018
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 Date01/26/2019
Device Model NumberU125
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 Received07/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2017
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
4456; ADSR01; MISMATCH; U125
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