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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 High impedance; Over-Sensing; Pacing Problem; Capturing Problem; Material Integrity Problem
Event Date 05/05/2016
Event Type  Malfunction  
Manufacturer Narrative

The lead was surgically abandoned and was not returned for testing. 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 during the elective procedure to replace this patient's competitive device, this lead was kinked during efforts to insert the lead into the header of the replacement device. Pacing therapy was intermittent due to oversensing, thresholds were high and pacing impedance measurements were greater than 2000 ohms on the right ventricular (rv) channel. The lead was removed from service and replaced. 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 Key5823968
Report Number2124215-2016-08799
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 05/05/2016
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 Date11/30/1994
Device MODEL Number4260
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 Received05/05/2016
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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