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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067); Complaint, Ill-Defined (2331)
Event Date 03/09/2018
Event Type  Injury  
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) was part of a system revision due to pocket infection and erosion. The patient also had sepsis and hematoma. In addition, the patient became hypotensive and desaturated during the extraction and the patient was taken to intensive care unit (icu) to stabilize. Additional information was received indicating that the crt-p was returned and a temporary pacing wire was inserted via the groin and attached to a standard temporary external pacemaker. The crt-p was explanted. No additional adverse patient effects were 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 Key7413403
MDR Text Key104915927
Report Number2124215-2018-06104
Device Sequence Number1
Product Code NKE
UDI-Device Identifier00802526559402
UDI-Public00802526559402
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 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/27/2018
Device Model NumberU128
Other Device ID NumberVALITUDE X4
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 Received03/09/2018
Was Device Evaluated by Manufacturer? No
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

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
Treatment
1888TC; 4674; S603; U128
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