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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 4260
Device Problems Over-Sensing; Pacing Problem; Ambient Noise Problem
Event Date 06/29/2016
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 while hospitalized for an unrelated cause, the patient implanted with this system experienced a heart rate of 20 bpm per external electrocardiogram but was noted to be asymptomatic. The device was interrogated and noise with oversensing was observed in both bipolar and unipolar configurations. Device sensitivity was reprogrammed but did not resolve the issue. Review of lead measurements noted they were consistent with past values. The patient was provided a temporary pacemaker and a procedure performed the following day wherein a new system was implanted on the side opposite their existing device and the chronic system was abandoned. No 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 Key5823819
Report Number2124215-2016-11660
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Type of Report Initial
Report Date 06/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/14/1992
Device MODEL Number4260
OTHER Device ID Number---
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/29/2016
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

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