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

Model Number 3716

Device Problems No Device Output (1435); Use of Device Problem (1670); Communication or Transmission Problem (2896)

Patient Problems Loss of Range of Motion (2032); Inadequate Pain Relief (2388)

Event Date 03/31/2015

Event Type  Injury  

Event Description

It was reported the patient (australia) lost stimulation and was unable to communicate with the ipg using two charging systems.The patient programmer gave a 'low battery- stim off' message.The patient admitted to not following the recommended charging protocol for the ipg.Due to loss of stimulation, the patient stated her mobility was affected.Subsequently, the patient's ipg was explanted and replaced.Stimulation was restored post-operatively.

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.

• Brand Name: EON RECHARGEABLE IPG, 16-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: 4772702
• MDR Text Key: 5782752
• Report Number: 1627487-2015-21121
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 04/28/2015

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: 03/28/2011
• Device Model Number: 3716
• Device Lot Number: 2770849
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2009
• 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 3342, SCS EXTENSION; MODEL 3186, SCS LEAD; MODEL 3156, SCS LEAD; MODEL 3153, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 38 YR