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 Inadequate Pain Relief (2388)

Event Date 01/05/2015

Event Type  Injury  

Event Description

It was reported the patient's programmer reflected a "low battery" warning.It was also reported the patient's ipg was depleted.As a result, the patient underwent surgical intervention on (b)(6) 2015, where the ipg was explanted and replaced which resolved the reported issue.

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

Results: the complaint for battery depletion was confirmed.The ipg was received in good condition and communicated with lab equipment.The lab patient programmer displayed a low battery warning.An estimate of longevity was made using the clinician manual and approximations of the downloaded patient parameters.Using the last known programmed settings, the expected longevity would have been approximately 8.6 months up to 120 months.The time between implant and the event date was approximately 34 months.This is considered to be normal battery depletion.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, texas
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4456093
• MDR Text Key: 5320993
• Report Number: 1627487-2015-23043
• 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
• 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: Other
• Device Expiration Date: 01/28/2014
• Device Model Number: 3688
• Device Lot Number: 3591359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 01/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2012
• 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 3286 (2), SCS LEAD, IMPLANT DATE; MODEL 1192 (2), SCS ANCHOR, IMPLANT DATE
• Patient Outcome(s): Other
• Patient Age: 79 YR