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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HISTORICAL CPI ST. PAUL TRANSVENOUS IMPLANTABLE LEAD

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HISTORICAL CPI ST. PAUL TRANSVENOUS IMPLANTABLE LEAD Back to Search Results
Model Number 4261
Device Problems Over-Sensing; Pacing Problem; Ambient Noise Problem
Event Date 12/13/2016
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 pacemaker right atrial (ra) and right ventricular (rv) lead exhibited noise, oversensing and pacing inhibition that resulted in greater than 2 seconds of asystole. The patient was pacemaker dependent. Programming changes to sensitivity was initial attempted, however, did not resolve the observations. An invasive procedure was performed. This system was programmed vvi 40 and was left implanted on the right side for backup pacing and a new system was implanted on the left side. The physician plans to program this system off at the patient's two week follow up. No additional adverse patient effects were reported.

 
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Brand NameTRANSVENOUS
Type of DeviceIMPLANTABLE LEAD
Manufacturer (Section D)
HISTORICAL CPI ST. PAUL
guidant corporation
saint paul MN
Manufacturer (Section G)
HISTORICAL CPI ST. PAUL
guidant corporation
saint paul MN
Manufacturer Contact
sonali vasekar
4100 hamline ave. n
st. paul , MN 
6515824786
MDR Report Key6250729
Report Number2124215-2016-21156
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/04/1996
Device MODEL Number4261
OTHER Device ID Number---
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 Received12/13/2016
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

Patient TREATMENT DATA
Date Received: 01/13/2017 Patient Sequence Number: 1
Treatment
0937
4261
4269
K173
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