MAUDE Adverse Event Report: MEDTRONIC, INC. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37642
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id: neu_unknown, serial# unknown, product type: programmer antenna.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 a patient who was implanted with an implantable neurostimulator (ins) for essential tremor and movement disorders.It was reported the patient programmer worked sometimes and sometimes it did not.The caller was unsure if it was the cable.When the patient tried to decrease the stimulation it would not connect, it made a noise and an info screen appeared.The problem has gotten worse.The caller was unsure what screen it showed when it didn't work.The caller noted they would call back when the patient was available to determine what screen came up.Additional information was received indicating there was poor communication due to the programmer, beginning several weeks ago; this occurred with and without the antenna.The caller alleged the antenna was damaged.No patient symptoms or further complications were reported as a result of this event.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6714092
• Report Number: 2182208-2017-01038
• Device Sequence Number: 590246
• Product Code: MHY
• UDI-Device Identifier: 00613994691392
• UDI-Public: 00613994691392
• Combination Product (Y/N): N
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2017

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: 10/28/2013
• Device Model Number: 37642
• Device Catalogue Number: 37642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR