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

Model Number 3788

Device Problems No Device Output (1435); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/20/2014

Event Type  Injury  

Event Description

It was reported the patient experienced loss of stimulation as the patient was unable to establish communication between the ipg and external devices.A sjm representative confirmed the issue by using multiple external devices.Surgical intervention will be taken at a later date to address the issue.

Event Description

Further follow up identified the scs ipg was explanted and replaced with another model which resolved the issue.Reportedly, the patient has effective therapy postoperatively.

Manufacturer Narrative

Udi(di): (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

Result: the reported communication issue was confirmed.As returned, the ipg¿s battery was depleted below the minimum voltage to sustain communication and stimulation.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.It passed all tests.After the depleted battery was recovered, the returned ipg displayed normal device characteristic.The reason for the depleted battery was not 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 MINI IPG, 16-CHANNEL RECHARGEABLE
• 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
• Manufacturer Contact: taruna sharma
• MDR Report Key: 4392951
• MDR Text Key: 5127227
• Report Number: 1627487-2015-20007
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2015

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: 10/28/2013
• Device Model Number: 3788
• Device Lot Number: 3533851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 01/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/05/2015; 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2011
• 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 1192(2) SCS ANCHOR; MODEL 3186 (2), SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 65 YR