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) QUARTET; PERMANENT PACEMAKER ELECTRODE
  • 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) QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/75
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/03/2021
Event Type  malfunction  
Event Description
It was reported that during implant, the connector adapter sleeve would not go completely over the lead pin.The adapter was replaced but the same issue was seen.The lead was removed and a new lead was used instead.The patient was in stable condition.
 
Manufacturer Narrative
The reported events of lead pin not fully inserting into the connector adaptor was confirmed.As received, a complete lead was returned for evaluation, measuring 75.3 cm.Electrical tests did not find any anomalies.The lead connector passed insertion testing into the test implantable cardioverter defibrillator device, but failed insertion testing into the test is-4 connector sleeve.Dimensional analysis of the connector identified an over-sized diameter in a section of the connector boot.This may have contributed to the reported field event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUARTET
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key11842624
MDR Text Key251207946
Report Number2017865-2021-18379
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503334
UDI-Public05414734503334
Combination Product (y/n)Y
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Model Number1458Q/75
Device Catalogue Number1458Q-75
Device Lot NumberA000106563
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/02/2021
Was the Report Sent to FDA? No
Date Manufacturer Received06/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-