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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUARTET; PERMANENT PACEMAKER ELECTRODE

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ST. JUDE MEDICAL, INC. QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problems Device Dislodged or Dislocated (2923); No Pacing (3268)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/31/2017
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
During a follow-up, the device was interrogated and there was no pacing on the left ventricular (lv) lead.Fluoroscopic imaging was performed and it was confirmed that the lv lead was dislodged.A lead repositioning procedure is anticipated.Further information was requested but not yet received.
 
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Brand Name
QUARTET
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6795125
MDR Text Key82712518
Report Number2017865-2017-08127
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeIT
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 08/15/2017
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 Date11/30/2019
Device Model Number1458Q/86
Device Lot NumberA000033222
Other Device ID Number05414734503198
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/31/2017
Initial Date FDA Received08/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/15/2016
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) Hospitalization; Required Intervention;
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