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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 Device Inoperable (1663)
Patient Problem Inadequate Pain Relief (2388)
Event Date 07/03/2015
Event Type  Injury  
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.
 
Event Description
It was reported the patient's ((b)(6)) ipg depleted.As a result, the patient underwent surgical intervention to explant and replace the ipg with a different model which resolved the issue.It is unknown if the depletion of the ipg was premature due to lack of the patient's settings and implant date.
 
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 lost stimulation and was unable to communicate with the patient programmer prior to the ipg replacement procedure.
 
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 Key5129848
MDR Text Key27553049
Report Number1627487-2015-25156
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Followup,Followup
Report Date 11/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2015
Device Model Number3608
Device Lot Number4339710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received11/17/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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