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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)
Patient Problem Twiddlers Syndrome (2114)
Event Type  Injury  
Manufacturer Narrative
This product is registered as a combination product.
 
Event Description
It was reported that the left ventricular (lv) lead was explanted due to twiddler's syndrome.The lv lead was replaced.The patient was stable with no adverse health consequences.
 
Manufacturer Narrative
Correction: section h6 device code should have been 2923 - device dislodged or dislocated rather than 1395 - migration or expulsion of device.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
QUARTET
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key10861568
MDR Text Key216890559
Report Number2938836-2020-09344
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
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,Followup,Followup
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model Number1458Q/86
Device Catalogue Number1458Q-86
Device Lot NumberA000093357
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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