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

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.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 1 of 2.Reference mfr.Report# 1627487-2015-20561.It was reported the patient ((b)(6)) experienced pocket heating while charging (event date unknown).The charger was replaced with a different model which resolved the issue.Device information is unknown for the ipg and the charger.

• 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; st. jude medical - neuromodulation; plano TX 75024
• MDR Report Key: 5128525
• MDR Text Key: 27503895
• Report Number: 1627487-2015-20560
• 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: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Report Date: 09/10/2015

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other