MAUDE Adverse Event Report: ST JUDE MED - NEUROMODULATION GENESIS; SCS IPG

Model Number 3608

Device Problems Premature End-of-Life Indicator (1480); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 07/15/2014

Event Type  Injury  

Event Description

It was reported the pt (b)(6) experienced heating at the ipg site whether stimulation was on or off.It was also reported the pt received a low battery warning due to possible premature battery depletion.In turn, the pt lost stimulation.As a result, the pt's ipg was explanted and replaced (with a different model).The replacement ipg resolved the pt's issues.

Manufacturer Narrative

Results: the complaint for depleted battery was not confirmed.As received, the ipg communicated with lab equipment.The lab pt programmer displayed the low battery warning.Analysis revealed the low battery warning was due to passivation.The low battery warning was cleared followed by a pulse load test to clear the passivation from the battery.After the pulse load test, the low battery flag did not reappear.The complaint of pt discomfort due to heating at the ipg site whether stimulation was on or off was not confirmed.As received, the ipg was in good condition.Monitoring stimulation did not reveal any anomalous outputs or degradation of programmed outputs.No physical or functional anomalies were observed which could have contributed to this complaint.The ipg was tested to mfg specifications using the autotester.The ipg passed all tests on the autotester.Sjm has limited information related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: GENESIS
• Type of Device: SCS IPG
• Manufacturer (Section D): ST JUDE MED - NEUROMODULATION; plano TX
• Manufacturer Contact: drew johnson ; 6901 preston rd.; plano, TX 75024 ; 9725264667
• MDR Report Key: 4135668
• MDR Text Key: 4793511
• Report Number: 1627487-2014-05681
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: 3608
• Device Lot Number: 4158927
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other