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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 Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
This product is registered as a combination product.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 to the clinic for a follow up.Interrogation showed the patient's left ventricular (lv) lead capture threshold was high.A chest x-ray was performed which showed the lv lead had dislodged.The patient was asymptomatic.No changes have been made.
 
Event Description
Additional information received indicated that the patient's left ventricular lead was programmed off.
 
Manufacturer Narrative
Additional information: b1, b2, b5, d7, h1.
 
Event Description
Additional information received indicated that the patient's left ventricular lead was explanted and replaced.The patient was stable throughout.
 
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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
MDR Report Key11084676
MDR Text Key224029341
Report Number2017865-2020-23727
Device Sequence Number1
Product Code OJX
UDI-Device Identifier05414734510189
UDI-Public05414734510189
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,foreig
Type of Report Initial,Followup,Followup
Report Date 01/11/2021
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 Date07/31/2022
Device Model Number1457Q/86
Device Catalogue Number1457Q/86
Device Lot NumberA000084920
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/14/2020
Initial Date FDA Received12/28/2020
Supplement Dates Manufacturer Received01/02/2020
01/11/2021
Supplement Dates FDA Received01/05/2021
01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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