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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD DOUBLE BEND, 86 CM; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1457Q/86
Device Problems Signal Artifact/Noise (1036); Break (1069); Therapy Delivered to Incorrect Body Area (1508); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
Event Description
It was reported that the patient presented experiencing phrenic nerve stimulation.Upon interrogation, it was noted that the left ventricular - lv lead exhibited noise.A chest x-ray was performed and the lv lead was found to be dislodged.During the procedure, the stylet failed to disconnect from the lv lead causing damage.The lv lead was explanted and replaced.The patient was in stable condition before, during, and after the procedure.
 
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Brand Name
QUARTET LEAD DOUBLE BEND, 86 CM
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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key12396127
MDR Text Key269434151
Report Number2017865-2021-29478
Device Sequence Number1
Product Code OJX
UDI-Device Identifier05414734510189
UDI-Public05414734510189
Combination Product (y/n)Y
Reporter Country CodeAR
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 08/31/2021
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 Date12/31/2021
Device Model Number1457Q/86
Device Catalogue Number1457Q/86
Device Lot NumberA000072129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/23/2021
Initial Date FDA Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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