MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON C 16-CHANNEL IPG; SCS IPG

Model Number 3688

Device Problem Low Battery (2584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2015

Event Type  Injury  

Event Description

It was reported the patient's ((b)(6)) ipg is displaying a 'low battery' indication which was confirmed by the sjm representative.Surgical intervention will take place to address the issue.

Event Description

Follow-up identified the patient did not lose stimulation due to the low battery indication.Subsequently, the ipg was explanted and replaced.Effective stimulation was restored post-surgery.

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.

Manufacturer Narrative

Results: a visual inspection of the ipg as received did not reveal any abnormalities.Communication with the device was normal when using a patient programmer and grey screen utility.During initial communication, an ipg low battery message was observed on the patient programmer.Electrical current characterization of the ipg current draw using the last known programmed settings was performed and it was determined the ucod (u2) voltage multiplier circuitry was not decrementing properly.The device was programmed to the as received settings of 60hz, 375us, 4.8ma in a continuous stimulation mode and attached to a 1k ohm lead.The ipg current draw from the battery was monitored and averaged 415ua with a vmultiplier voltage of 13.68v at tp27.A control device programmed to the same parameters averaged a current draw of 190ua with a vmultiplier voltage of 5.89v.When the vmultiplier voltage is at the maximum of 13.68v, the device was drawing excess current which resulted in the device battery depleting sooner than expected.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

Evaluation codes: results: additional device analysis was warranted to better ensure device functionality.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.Electrical pulse load testing confirmed the device battery voltage was low.Following up electrical testing determined the device was functioning within specification.When programming the device at 3 different settings and ensuring the correct calibration factors had been down loaded into the device, it was concluded the device was functioning within the electrical specifications.A review of the communication history noted that no programming history or lead impedances were provided.Based on the insufficient information concerning the programming and lead impedance history an accurate longevity could not be performed.The device was performing in electrical specification during testing and the root cause of the depleted battery could not be ascertained.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: EON C 16-CHANNEL IPG
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, tx
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4466435
• MDR Text Key: 5182384
• Report Number: 1627487-2015-21029
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 05/20/2015

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 Date: 01/28/2014
• Device Model Number: 3688
• Device Lot Number: 3590352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 01/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2015; 05/05/2015; 06/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2012
• 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
• Treatment: MODEL 3228, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 74 YR