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

Model Number	37642
Medical Device Problem Codes	Failure to Interrogate (1332); Device Displays Incorrect Message (2591); 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	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the programmer (serial no.(b)(4)) found no significant anomaly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for parkinson¿s dual and movement disorders.It was reported there was poor communication on/with the programmer unit.The patient stated that it appeared the programmer antenna was not working anymore because they could not connect to their ins while using the programmer with the antenna plugged in.There was no telemetry with the antenna attached.The patient stated they could connect just fine when the antenna was disconnected.No patient symptoms or harm were reported in the event.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Follow up information received from the patient reported that the replacement programmer resolved the telemetry issue.There were no further complications reported or anticipated.

• 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: 7162342
• Report Number: 2182208-2018-00001
• Device Sequence Number: 13788160
• Product Code: MHY
• UDI-Device Identifier: 00643169273450
• UDI-Public: 00643169273450
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• 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
• Report Date (Section B): 02/13/2018

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 Model Number: 37642
• Device Catalogue Number: 37642
• Device Lot Number: NJZ149255N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 111