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

Model Number	37642
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system and other applicable components are : product id; 37092, product type: accessory.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 parkinson's dual and movement disorders.Patient reported getting poor communication with the antenna.Prior to the report, patient tried without the antenna.It was reviewed for patient to place the patient programmer (pp) directly over the ins and sync with the ins, and this resolved the poor communication.The pp antenna is reported to be damaged.It was noted that the patient uses the antenna.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
Other applicable components are : product id: 37092, serial# unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the patient stating that their problem was resolved with the replacement pp antenna.Patient was grateful for the prompt and courteous service.

• 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: 7836705
• Report Number: 2182208-2018-01584
• Device Sequence Number: 1286794
• Product Code: MHY
• UDI-Device Identifier: 00643169273450
• UDI-Public: 00643169273450
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/31/2018
• Supplement Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 69