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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 1458QL/92
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The results of the investigation are unconfirmed since the device was not returned for analysis.Based on the information received, the cause of the reported incident remains unconfirmed.
 
Event or Problem Description
It was reported that following an attempt at cardiopulmonary resuscitation (cpr), the left ventricular lead dislodged into the main coronary sinus.The lead was extracted and replaced.There were no complaints on the defibrillator which was replaced during the lead extraction.No further information was available.The patient was stable and recovering.
 
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Brand Name
QUARTET
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key9527381
Report Number2017865-2019-18524
Device Sequence Number2769275
Product Code NIK
UDI-Device Identifier05414734510226
UDI-Public05414734510226
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P030054
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/27/2019
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
Operator of Device Health Professional
Device Expiration Date08/31/2020
Device Model Number1458QL/92
Device Catalogue Number1458QL/92
Device Lot NumberA000045218
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/09/2019
Initial Report FDA Received Date12/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age62 YR
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