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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 Fracture (1260); High impedance (1291); No Pacing (3268)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2017
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
Related manufacturer report number: 2017865-2017-02228.There was high impedance with no pacing on the right atrial (ra) and left ventricular (lv) leads due to conductor fractures.Both leads were explanted and replaced and the patient was stable.
 
Manufacturer Narrative
As received, a partial lead (connector end) was returned for evaluation in one piece.Visual inspection of the lead revealed a breach of all the lumens, fracturing all the cables and all four filars of the inner coil distal to the suture sleeve tie impression.The cause of the reported events was consistent with clavicle crush.
 
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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 Key6486950
MDR Text Key72600700
Report Number2017865-2017-02227
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 01/30/2019
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 Date05/31/2018
Device Model Number1458Q/86
Device Lot NumberA000007803
Other Device ID Number05414734503198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2017
Initial Date FDA Received04/12/2017
Supplement Dates Manufacturer Received01/18/2019
Supplement Dates FDA Received01/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2015
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
TENDRIL STS (B)(4)
Patient Outcome(s) Hospitalization; Required Intervention;
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