MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION CHARGING SYSTEM RECHARGEABLE IPG; SCS CHARGING SYSTEM

Model Number 3701

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This ipg serial number was included in a field correction.The investigation for capa 118058 associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns.The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating 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.

Event Description

Device 2 of 2.Reference mfr.Report: 1627487-2016-04861.The patient reported experiencing heating at her scs ipg pocket site while charging and as a result was unable to fully charge her scs ipg.Subsequently, the patient received a replacement charging system which did not resolve the issue.The patient's scs ipg was explanted and replaced with a different model.No further issues regarding the event have been reported following the surgical intervention.On (b)(6) 2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.An increase in prior non-reported heating while charging events and other non-reported events was expected.

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.

Event Description

Device 2 of 2.Reference mfr.Report: 1627487-2016-04861.Additional information received identified that prior to the patient's scs ipg being explanted and replaced, the patient was no longer able to establish communication between the device and the charging system.As a result, the scs ipg battery ran low and the patient lost stimulation.It was also reported the patient experienced pocket stimulation while charging.A replacement charging system was tried to no avail.No further issues regarding these events have been reported following the surgical intervention.

• Brand Name: CHARGING SYSTEM RECHARGEABLE IPG
• Type of Device: SCS CHARGING SYSTEM
• 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: 5961087
• MDR Text Key: 55096872
• Report Number: 1627487-2016-04862
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

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: 12/03/2012
• Device Model Number: 3701
• Device Lot Number: 98033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Treatment: MODEL 3268, SCS LEAD
• Patient Outcome(s): Other