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

Model Number	37642
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are : product id 37092, product type accessory.Information references the main component of the system.Other relevant device(s) are: product id: 37092.Date of the event (b)(6) 2018 is an estimate.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 neuro stimulator (ins) for essential tremor and movement disorders.Patient reported that they took their patient programmer (pp) to their neurologist office and they said it was not working, advised the patient to call the manufacturer.Patient stated that the antenna was not working and was showing poor communication/ pp won't do telemetry with antenna attached.Patient stated that they put new batteries in the pp last week.It was noted that the patient uses an antenna.It was reviewed for the patient to place the pp directly over the ins and sync with the ins, and the poor communication was resolved/connected successfully.No patient symptoms were reported.A replacement pp antenna was sent to the patient.No further patient complications were reported/ anticipated as a result of this event.
Additional Manufacturer Narrative
Additional concomitant medical products reference the main component of the system and other applicable components are : product id: (b)(4); serial# :unknown; product type: accessory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the patient indicating the new programmer antenna resolved the poor communication issue between the programmer and the ins.No further patient complications were reported/ anticipated as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7681151
• Report Number: 2182208-2018-01277
• Device Sequence Number: 16331583
• Product Code: MHY
• UDI-Device Identifier: 00643169518933
• UDI-Public: 00643169518933
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 10/05/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 07/27/2018; 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/31/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 61