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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GENESISXP PULSE GENERATOR, DUAL 4 CH.; SCS IPG
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ST. JUDE MEDICAL - NEUROMODULATION GENESISXP PULSE GENERATOR, DUAL 4 CH.; SCS IPG Back to Search Results
Model Number 3644
Device Problems Device Remains Activated (1525); Device Stops Intermittently (1599)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Event Description
It was reported the patient's ipg has been turning off by itself but sometimes won't turn off after deactivation.The event date is unknown.The doctor believes it is due to the ipg being over 10 years old.As a result, the patient will undergo surgical intervention.
 
Manufacturer Narrative
(b)(4).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.
 
Event Description
Follow-up revealed the patient's ipg was no longer functional.As a result, the 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
Follow-up revealed the explant date is (b)(6) 2015 not (b)(6) 2015.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
GENESISXP PULSE GENERATOR, DUAL 4 CH.
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 Key4614717
MDR Text Key15126534
Report Number1627487-2015-07125
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative,company representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 11/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2006
Device Model Number3644
Device Lot Number33226A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/25/2015
Initial Date FDA Received03/18/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/16/2015
12/18/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2004
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;
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