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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) SUSTAIN XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) SUSTAIN XL SR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM1136
Medical Device Problem Code Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/12/2018
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 the patient presented in clinic for follow-up.It was noted that the pulse generator was in back-up.A day before, the patient presented in the operating room for an unrelated procedure.The device was functioning prior to the surgery hence, it was suspected that cautery used during the surgery might have caused the device reset.A device restoration was performed successfully.
 
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Brand Name
SUSTAIN XL SR
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key7701103
Report Number2017865-2018-10557
Device Sequence Number19058485
Product Code LWP
UDI-Device Identifier05414734504737
UDI-Public05414734504737
Combination Product (Y/N)N
Initial Reporter CountryEG
PMA/510(K) Number
P880086
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/18/2018
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 Date04/30/2018
Device Model NumberPM1136
Device Lot NumberS000027304
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 07/12/2018
Initial Report FDA Received Date07/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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