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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1456Q/86
Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Patient Problem Twiddlers Syndrome (2114)
Event Date 12/18/2020
Event Type  Injury  
Manufacturer Narrative
This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that patient presented with loss of capture from their left ventricular lead.An x-ray revealed the patient had twiddled their device leading to lead dislodgement.The lead was explanted on (b)(6) 2020.A new lead was not implanted due to vein occlusion.Patient was stable after the procedure.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
QUARTET LEAD SMALL-S, 86 CM
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11131938
MDR Text Key225530192
Report Number2017865-2021-00845
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734510158
UDI-Public05414734510158
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2021
Device Model Number1456Q/86
Device Catalogue Number1456Q/86
Device Lot NumberA000070326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/22/2020
Initial Date FDA Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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