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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. SUSTAIN XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC. SUSTAIN XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2136
Device Problem Programming Issue (3014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.(b)(4).
 
Event Description
The physiologist was unable to program the appropriate rate response for the device.Technical services recommended device reprogramming to resolve the issue.
 
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Brand Name
SUSTAIN XL DR
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.
15900 valley view court
sylmar CA 91342
Manufacturer Contact
denise johnson
5050 nathan lane north
plymouth, MN 55442
6517564470
MDR Report Key6292326
MDR Text Key66490720
Report Number2017865-2017-00583
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P880086
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2015
Device Model NumberPM2136
Device Lot Number4147524
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/04/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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