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

Model Number	3730
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 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.The manufacturer defers to the patient's physician regarding medical history.
Event or Problem Description
The patient's son reported the patient's charging unit emanated a burning smell approximately a month ago.As such, the product was discarded due to the issue.A replacement charging system was sent to the patient.

• Brand Name: PRODIGY CHARGING SYSTEM
• Common Device Name: SCS CHARGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7813940
• Report Number: 1627487-2018-07727
• Device Sequence Number: 1808604
• Product Code: LGW
• UDI-Device Identifier: 05414734405492
• UDI-Public: 05414734405492
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2017
• Device Model Number: 3730
• Device Catalogue Number: 3730
• Device Lot Number: 5689699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1