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

Model Number 6661

Device Problems Wireless Communication Problem (3283); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2018

Event Type  malfunction  

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 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.

Manufacturer Narrative

Evaluation codes and description of event were unintendedly incorrect in the initial report.This report contains correct information.

Event Description

Additional information gathered identified the patient's ipg failed to communicate with the clinician programmer.Reportedly, the patient has stimulation.

• Type of Device: DBS 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: falon whitfield ; 6901 preston road; plano, TX 75024 ; 9725268233
• MDR Report Key: 7992299
• MDR Text Key: 124608983
• Report Number: 1627487-2018-10365
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020253
• UDI-Public: 05415067020253
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Model Number: 6661
• Device Lot Number: 6099535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-060217-001-C
• Patient Sequence Number: 1