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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458Q/86
Device Problems Device Dislodged or Dislocated (2923); Impedance Problem (2950); High Capture Threshold (3266)
Patient Problems Undesired Nerve Stimulation (1980); No Known Impact Or Consequence To Patient (2692)
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
It was reported that the patient experienced phrenic nerve stimulation and presented via remote transmission, high capture threshold was noted on the left ventricular lead.The patient presented in clinic later with symptoms of phrenic nerve stimulation.Review of impedance trends noted that there was a drop in pacing impedance measurements on the left ventricular lead about couple weeks prior to clinic visit, and then arose to normal impedance measurements during clinic visit.Programming changes were made to temporarily resolve intermittent phrenic nerve stimulation.A chest x-ray was performed.Lead revision was discussed.The patient was stable post interrogation.
 
Event Description
New information was received noting that the left ventricular lead was dislodged and had migrated to the superior vena cava.The lead was explanted and replaced.The patient was stable before, during, and after surgery.
 
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.
 
Manufacturer Narrative
The reported events were not confirmed.As received a complete lead was returned in one piece measuring 86.1 cm.Analysis was normal.No anomalies were found.
 
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Brand Name
QUARTET
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key9392469
MDR Text Key168598964
Report Number2938836-2019-16767
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734503198
UDI-Public05414734503198
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,foreig
Type of Report Initial,Followup,Followup
Report Date 07/30/2020
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 Date02/28/2022
Device Model Number1458Q/86
Device Catalogue Number1458Q-86
Device Lot NumberA000076376
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2019
Initial Date FDA Received11/30/2019
Supplement Dates Manufacturer Received06/10/2020
07/29/2020
Supplement Dates FDA Received06/15/2020
07/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age77 YR
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