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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5376
Medical Device Problem Code Failure to Interrogate (1332)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/08/2019
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that the patient presented for routine followup in clinic.Several attempts were made to interrogate the pacemaker, but each attempt was unsuccessful.Patient was not device dependent.Pacemaker explant procedure was discussed.Patient was stable.
 
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Brand Name
IDENTITY XL DR
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 Key8818868
Report Number2017865-2019-11250
Device Sequence Number13567351
Product Code LWP
UDI-Device Identifier05414734006880
UDI-Public05414734006880
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2003
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/23/2019
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 Date02/28/2005
Device Model Number5376
Device Lot Number0002281144
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 07/08/2019
Initial Report FDA Received Date07/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age67 YR
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