MAUDE Adverse Event Report: MEDTRONIC, INC.; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	97740
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain and other chronic/intract pain.It was reported that the patient saw a "in-the-box" icon on the patient programmer.The rep will meet with the patient to clear the error.Technical services that this is related to using the antenna locate feature.No symptoms were reported.No further complications were reported or anticipated.
Additional Manufacturer Narrative
As the initial report stated that there was an adverse event, which did no occur.The issue was strictly a product problem.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6558789
• Report Number: 2182208-2017-00692
• Device Sequence Number: 614195
• Product Code: LGW
• UDI-Device Identifier: 00643169109476
• UDI-Public: 00643169109476
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2017

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
• Operator of Device: Health Professional
• Device Model Number: 97740
• Device Catalogue Number: 97740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided; 05/18/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/18/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR