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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5376
Medical Device Problem Code Connection Problem (2900)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/11/2018
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 during device change-out procedure, atrial set screw was stuck in the header and atrial lead could not be removed.Further investigation revealed a piece of grommet which was slightly obscuring the set screw hole.Device was explanted and replaced.Patient¿s condition 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-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key7617574
Report Number2938836-2018-08046
Device Sequence Number2292445
Product Code LWP
UDI-Device Identifier05414734006880
UDI-Public05414734006880
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2002
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/19/2018
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 Date11/30/2003
Device Model Number5376
Device Lot Number0002295457
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 06/11/2018
Initial Report FDA Received Date06/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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