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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD SUSTAIN XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC., CRMD SUSTAIN XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM2136
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/29/2014
Event Type  malfunction  
Event Description
It was reported that during the implant procedure when the leads were connected to the pulse generator, no output was noted.The device was not used and replaced.
 
Manufacturer Narrative
All information provided by manufacturer, no medwatch form was received.(b)(4).Evaluation description included.Final analysis found normal device characteristics.
 
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Brand Name
SUSTAIN XL DR
Type of Device
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC., CRMD
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jennie hamel
15900 valley view court
sylmar, CA 91342
8184933462
MDR Report Key4228922
MDR Text Key18872573
Report Number2017865-2014-17814
Device Sequence Number1
Product Code DXY
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2015
Device Model NumberPM2136
Device Catalogue NumberSMTFY999
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/01/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PM2136, 2972035
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