• 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-SUNNYVALE) QUICKSITE LV; 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-SUNNYVALE) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1056T/86
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/21/2020
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 reference number: 2938836-2020-07920, 2938836-2020-07921, 2938836-2020-07922.It was reported that the biventricular implantable cardiac defibrillator system was explanted due to lead noise.A new icd, atrial lead, and right ventricular lead were implanted on (b)(6) 2020.New epicardial left ventricular leads were implanted on (b)(6) 2020.The patient was discharged in stable condition.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
QUICKSITE LV
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key10417875
MDR Text Key203272549
Report Number2938836-2020-07923
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 08/17/2020
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 Date05/31/2010
Device Model Number1056T/86
Device Lot Number0002114928
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/27/2020
Initial Date FDA Received08/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/11/2007
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
RIATA ACTIVE FIXATION.; TENDRIL STS.; UNIFY CRT-D.
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight91
-
-