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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUICKSITE LV; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1056T/86
Device Problems Signal Artifact/Noise (1036); Degraded (1153)
Patient Problems Arrhythmia (1721); Erosion (1750); Discomfort (2330)
Event Date 08/18/2021
Event Type  Injury  
Event Description
Related manufacturer's reference number: 2017865-2021-29639.Related manufacturer's reference number: 2017865-2021-29641.It was reported the patient presented remotely with several events of ventricular tachycardia.The patient's device was determined to be at eri and was replaced, and that the defibrillation shocks were unsuccessful.Upon surgery to remove the implantable cardioverter defibrillator, it was observed the right ventricular lead had externalized conductors, and was capped.The left ventricular lead had insulation fraying, and was repaired with medical adhesive.The right atrial lead had melted to the can, and was repaired with medical adhesive.The patient was in stable condition.
 
Manufacturer Narrative
Correction: h6.
 
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Brand Name
QUICKSITE LV
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key12414344
MDR Text Key269546787
Report Number2017865-2021-29640
Device Sequence Number1
Product Code OJX
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,health
Type of Report Initial,Followup
Report Date 09/07/2021
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 Date12/31/2008
Device Model Number1056T/86
Device Lot Number0002117959
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/23/2021
Initial Date FDA Received09/02/2021
Supplement Dates Manufacturer Received08/18/2021
Supplement Dates FDA Received09/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RIATA; TENDRIL ST; RIATA; TENDRIL ST
Patient Outcome(s) Required Intervention;
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