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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP; IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3542
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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
It was reported that during implant procedure on an unknown date the pacemaker set screw would not tighten.The physician elected to use a different device to complete the procedure.The patient condition was stable.
 
Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
Event Description
New information indicates that the event was noted during an unrelated procedure in (b0(6) 2021.
 
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Brand Name
QUADRA ALLURE MP
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11600527
MDR Text Key243326335
Report Number2017865-2021-13439
Device Sequence Number1
Product Code NKE
UDI-Device Identifier05414734510080
UDI-Public05414734510080
Combination Product (y/n)N
PMA/PMN Number
P030035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 11/03/2021
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 Health Professional
Device Expiration Date06/30/2021
Device Model NumberPM3542
Device Catalogue NumberPM3542
Device Lot NumberP000094461
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/18/2021
Initial Date FDA Received03/31/2021
Supplement Dates Manufacturer Received06/24/2021
10/11/2021
10/20/2021
Supplement Dates FDA Received06/24/2021
10/15/2021
11/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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