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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT ACCEL VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CURRENT ACCEL VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD1215-36Q
Medical Device Problem Code Over-Sensing (1438)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/13/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for follow-up.Upon interrogation, the implantable cardioverter defibrillator (icd) exhibited post sensed t-wave over-sensing (pstwos) during episodes of supraventricular tachycardia (svt).No intervention was performed.Patient condition was stable.
 
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Brand Name
CURRENT ACCEL VR ICD
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key12566461
Report Number2017865-2021-32268
Device Sequence Number13787289
Product Code NVZ
UDI-Device Identifier05414734503044
UDI-Public05414734503044
Combination Product (Y/N)N
Initial Reporter CountrySN
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/31/2014
Device Model NumberCD1215-36Q
Device Catalogue NumberCD1215-36Q
Device Lot Number3950257
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 09/13/2021
Initial Report FDA Received Date10/02/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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