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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CRM ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT CRM ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5157M/S
Medical Device Problem Code Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/13/2019
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
During follow-up, false elective replacement indicator (eri) was noted on the device.The device was reprogrammed and restored to resolve the event.The patient was in stable condition.
 
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Brand Name
ADX XL DR
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT CRM
15900 valley view court
sylmar CA 91342
MDR Report Key8655345
Report Number2017865-2019-08243
Device Sequence Number16616650
Product Code LWP
UDI-Device Identifier05414734006774
UDI-Public05414734006774
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/30/2019
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 Date03/31/2006
Device Model Number5157M/S
Device Lot Number3047221
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 05/15/2019
Initial Report FDA Received Date05/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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