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

Model Number UNKNOWN

Device Problem Temperature Problem (3022)

Patient Problem Burning Sensation (2146)

Event Date 08/10/2018

Event Type  Injury  

Manufacturer Narrative

This ipg serial number was included in field correction.Manufacturer 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.Manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2, reference mfr.Report#: 1627487-2018-08504.It was reported ((b)(6)) the patient was experiencing uncomfortable pocket heating while charging.No additional information available at this time.Device information is unavailable at this time.

Event Description

Device 2 of 2; reference mfr.Report#: 1627487-2018- 08504.Additional information received identified the charger was replaced with a low energy charger which resolved the issue.

• 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 ; 6901 preston road; plano, TX 75024 ; 9725269635
• MDR Report Key: 7855439
• MDR Text Key: 119529368
• Report Number: 1627487-2018-08505
• Device Sequence Number: 1
• Product Code: LGW
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/07/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 09/25/2018
• 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