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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC. 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5356
Device Problem Difficult to Interrogate (1331)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2017
Event Type  malfunction  
Event Description
During follow-up, there was difficulty interrogating the device, which was found to have reached its normal elective replacement indicator (eri).The device was explanted and replaced and the patient was in stable condition following the procedure.
 
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Brand Name
5356 VERITY DR, AB 20 55 184
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
robert greenleaf
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key7313124
MDR Text Key101505801
Report Number2017865-2018-01626
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2008
Device Model Number5356
Device Lot Number2955398
Other Device ID Number05414734006835
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2006
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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