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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKFLEX LV LEAD; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1156T/75
Device Problem High impedance (1291)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2020
Event Type  malfunction  
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
Related manufacturer reference number: 2017865-2020-25309.It was reported that the patient presented remotely via merlin.Net.Upon review, it was discovered that the left ventricular lead exhibited high impedance.It was noted that the impedance was greater than 3,000 in bipolar and lv tip to rv coil.Further information was requested to identify if it was a header or lead issue however, additional information was not provided.There were no patient consequences.
 
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Brand Name
QUICKFLEX LV LEAD
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 Key11098941
MDR Text Key224522157
Report Number2017865-2020-25310
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/30/2020
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 No Information
Device Expiration Date01/31/2012
Device Model Number1156T/75
Device Lot Number2762858
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2020
Initial Date FDA Received12/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNIFY ASSURA CRT-D RF HV
Patient Age66 YR
Patient Weight79
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