MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION GENESIS PULSE GENERATOR, 8-CHANNEL; SCS IPG

Model Number 3608

Device Problem Communication or Transmission Problem (2896)

Patient Problem Device Overstimulation of Tissue (1991)

Event Type  Injury  

Event Description

It was reported the patient's (b)(6) ipg is no longer communicating after turning her scs system off for a few days due to experiencing overstimulation approximately two months ago.In turn, the patient underwent surgical intervention to explant and replace the ipg which resolved the issue.

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

Results: a visual inspection of the ipg did not reveal any discrepancies.Communication with the device as received was unsuccessful when using a patient programmer and wdl utility.Electrical testing of the ipg confirmed the ipg battery voltage was below the minimum to sustain communication and stimulation.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.The auto test confirmed the integrity of the header assembly to ensure there were no issues that could have contributed to the patient feeling a shocking sensation.The observation of the ipg not working was due to the ipg battery having a low voltage.The root cause of the low battery voltage was not ascertained.An accurate longevity of the ipg could not be performed as the programming history was unknown.The observation of shocking was not confirmed through product analysis.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.

• 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 Key: 4370846
• MDR Text Key: 5116331
• Report Number: 1627487-2014-25715
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2015
• Device Model Number: 3608
• Device Lot Number: 4185717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2013
• 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