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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5826
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
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 battery impedance increased.Premature battery depletion was suspected but could not be confirmed.Additional information was requested but was not available.The patient was stable and will continue to be monitored.There were no adverse consequences.
 
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Brand Name
IDENTITY XL DR
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key9681538
Report Number2017865-2020-01648
Device Sequence Number2814751
Product Code NVZ
UDI-Device Identifier05414734006880
UDI-Public05414734006880
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 04/28/2020
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 No Information
Device Expiration Date02/29/2012
Device Model Number5826
Device Catalogue Number5376
Device Lot Number3190172
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/22/2020
Supplement Date Received by Manufacturer03/27/2020
04/14/2020
Initial Report FDA Received Date02/07/2020
Supplement Report FDA Received Date04/13/2020
04/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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