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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GENESIS PULSE GENERATOR, 8-CHANNEL; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION GENESIS PULSE GENERATOR, 8-CHANNEL; SCS IPG Back to Search Results
Model Number 3608
Device Problem Premature Discharge of Battery (1057)
Patient Problem Inadequate Pain Relief (2388)
Event Date 10/27/2014
Event Type  Injury  
Event Description
It was reported the patient's (b)(6) programmer displayed a premature low battery flag on (b)(6) 2014.The patient was reprogrammed, but three hours later all impedances were high.The following day the ipg was unable to communicate with the programmer.The sjm representative attempted to clear the flag several times but the error returned.The following day the ipg was unable to communicate with the programmer.Surgical intervention is pending to address the issue.
 
Event Description
It was reported the patient's ipg was explanted and replaced.
 
Manufacturer Narrative
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
 
Manufacturer Narrative
Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
 
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Brand Name
GENESIS PULSE GENERATOR, 8-CHANNEL
Type of Device
SCS IPG
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ST. JUDE MEDICAL - NEUROMODULATION
6901 preston rd
plano TX 75024
MDR Report Key4272383
MDR Text Key5226846
Report Number1627487-2014-12792
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2016
Device Model Number3608
Device Lot Number4411123
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received12/17/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/09/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age38 YR
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