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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 Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 04/02/2018
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) recorded a code 1003 during pre-implant interrogation. Data analysis was recommended. Never in service. No patient involvement.
 
Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory analysis was completed and reviewed. Analysis confirmed the device recorded a code 1003 due to exposure to cold weather.
 
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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 Key7662703
MDR Text Key113167397
Report Number2124215-2018-11976
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 Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/27/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/22/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received09/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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