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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5356
Medical Device Problem Code No Pacing (3268)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/08/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the dependent patient presented in clinic for follow up.Upon device interrogation, the pulse generator exhibited no pacing.Programming changes were made at previous follow ups that did not help fix the problem.Provocative testing was performed, no issues were found.It was suspected that the device was not working.No further intervention was performed.The patient was stable and would be continued to be monitored.
 
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Brand Name
5356 VERITY DR, AB 20 55 184
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key12683399
Report Number2017865-2021-34955
Device Sequence Number11689009
Product Code DXY
UDI-Device Identifier05414734006835
UDI-Public05414734006835
Combination Product (Y/N)N
Initial Reporter CountryRS
PMA/510(K) Number
P880086
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) 10/22/2021
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 Date01/31/2014
Device Model Number5356
Device Catalogue Number5356
Device Lot Number3758343
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 10/08/2021
Initial Report FDA Received Date10/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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