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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV ACCOLADE IMPLANTABLE PULSE GENERATOR

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GUIDANT PUERTO RICO BV ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U128
Device Problem High impedance (1291)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 01/06/2017
Event Type  malfunction  
Manufacturer Narrative
A boston scientific technical services consultant documented and discussed the clinical observations with the caller. The consultant stated that as long as the measurements were appropriate in the programmed vector, it was acceptable. The caller stated that a fluoroscopy was not performed and therefore, the root cause of the clinical observations could was not determined. 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 system exhibited a pacing impedance measurement of greater than 3000 ohms in one configuration and 450 ohms in another configuration. It was noted that this patient has clostridium difficile (c-diff). No adverse patient effects were reported.
 
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Brand NameACCOLADE
Type of DeviceIMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
GUIDANT PUERTO RICO BV
Manufacturer (Section G)
GUIDANT PUERTO RICO BV
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul, MN 
6515824786
MDR Report Key6464531
MDR Text Key72129136
Report Number2124215-2017-03559
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
Report Date 01/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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