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

Model Number	6661
Medical Device Problem Codes	Wireless Communication Problem (3283); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is included in the neuromodulation implantable pulse generator (ipg) inoperable when exposed to monopolar electrosurgery advisory notice issued by abbott on 02 june 2017.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 or Problem Description
It was reported the patient's ipg failed to communicate with the clinician programmer.It was unknown if the patient underwent any procedures.Reportedly the patient has stimulation.
Additional Manufacturer Narrative
Evaluation codes and description of event were unintendedly incorrect in the initial report.This report contains correct information.
Event or Problem Description
Additional information gathered identified the patient's ipg failed to communicate with the clinician programmer.Reportedly, the patient has stimulation.

• Common Device Name: DBS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 7992299
• Report Number: 1627487-2018-10365
• Device Sequence Number: 1669693
• Product Code: MHY
• UDI-Device Identifier: 05415067020253
• UDI-Public: 05415067020253
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 08/30/2019
• Device Model Number: 6661
• Device Lot Number: 6099535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1627487-060217-001-C
• Patient Sequence Number: 1