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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IDENTITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT IDENTITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5286
Medical Device Problem Codes Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/05/2020
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 an in-clinic follow up, the device was interrogated and diagnostics concerns were noted on the device as some of the data were missing in the report.No intervention has been conducted at this time.The patient was stable with no consequences.
 
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Brand Name
IDENTITY ADX XL
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key10726380
Report Number2017865-2020-16051
Device Sequence Number14230988
Product Code DXY
UDI-Device Identifier05414734006828
UDI-Public05414734006828
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/23/2020
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 Date05/31/2011
Device Model Number5286
Device Catalogue Number5286
Device Lot Number2924675
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/23/2020
Supplement Date Received by Manufacturer10/23/2020
Initial Report FDA Received Date10/23/2020
Supplement Report FDA Received Date10/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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