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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1056T/86
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 02/20/2020
Event Type  malfunction  
Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found that a complete lead was returned in two pieces: the connector portion measured 22.0 cm while the distal portion measured 64.0 cm.Dissection beneath the lead insulation at the s-curve region found internal insulation abrasion breaching between ring electrode cable and inner coil lumens at 4.0 -5.0 cm from distal tip.The etfe cable coating was found to be intact in this location.Abbott is continuing to monitor this issue.
 
Event Description
This report is to advise of an event observed during analysis.
 
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Brand Name
QUICKSITE LV
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
MDR Report Key9814445
MDR Text Key182962896
Report Number2017865-2020-03376
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2010
Device Model Number1056T/86
Device Lot Number0002115128
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/20/2020
Initial Date FDA Received03/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/31/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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