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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT SUSTAIN XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ABBOTT SUSTAIN XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM1136
Medical Device Problem Codes Pacemaker Found in Back-Up Mode (1440); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/05/2021
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 device was found in back-up mode due to external interference following an unrelated procedure.Technical support was contacted and suggested reprogramming, which was performed to resolve the event.The patient was stable and there were no adverse consequences.
 
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Brand Name
SUSTAIN XL SR
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key11219088
Report Number2017865-2021-05954
Device Sequence Number4062323
Product Code NVZ
UDI-Device Identifier05414734504737
UDI-Public05414734504737
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
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) 07/30/2021
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 Date03/31/2014
Device Model NumberPM1136
Device Catalogue NumberPM1136
Device Lot Number3815973
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/06/2021
Supplement Date Received by Manufacturer07/30/2021
Initial Report FDA Received Date01/22/2021
Supplement Report FDA Received Date07/30/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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