Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3140
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/12/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2021-13534.Related manufacturer reference number: 2017865-2021-13536.It was reported that the patient was admitted to the hospital due to capsular infection and rupture.On (b)(6) 2021, the pacemaker and two leads were explanted and replaced.The patient was stable post procedure.
 
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUADRA ALLURE CRT-P
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11606404
Report Number2017865-2021-13533
Device Sequence Number3622014
Product Code NIK
UDI-Device Identifier05414734507899
UDI-Public05414734507899
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
P030035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 04/27/2021
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? No
Operator of Device Health Professional
Device Expiration Date02/29/2020
Device Model NumberPM3140
Device Catalogue NumberPM3140
Device Lot NumberS000064419
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/12/2021
Supplement Date Received by Manufacturer04/05/2021
Initial Report FDA Received Date04/01/2021
Supplement Report FDA Received Date04/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
QUARTET; TENDRIL STS; QUARTET; TENDRIL STS
Outcome Attributed to Adverse Event Required Intervention;
-
-