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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 No Pacing (3268)
Health Effect - Clinical Code Arrhythmia (1721)
Date of Event 06/28/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient presented in the emergency room with asystole.The patient's pacemaker had reached end of life (eol) and was unable to provide pacing support.The patient was resuscitated and intubated.The physician elected to implant a replacement pacemaker.The patient was recovering post procedure.
 
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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 Key12181772
Report Number2017865-2021-25726
Device Sequence Number16527194
Product Code DXY
UDI-Device Identifier05414734006880
UDI-Public05414734006880
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/07/2021
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 Date10/31/2012
Device Model Number5376
Device Catalogue Number5376
Device Lot Number3362701
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/28/2021
Supplement Date Received by Manufacturer10/04/2021
Initial Report FDA Received Date07/16/2021
Supplement Report FDA Received Date10/07/2021
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;
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