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

Model Number	37642
Medical Device Problem Codes	Failure to Interrogate (1332); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2017
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 patient with an implantable neurostimulator (ins) for unknown symptoms.The patient reported that they were having a lot of difficulty making the programmer work.The patient stated that it is sporadic, but sometimes it works fine and other times they have to mess with it for 5 minutes before it will finally function and get to the therapy screen.The patient confirmed the poor communication screen.The patient connected the antenna, tried to sync and it did not resolve the issue.The patient then synced with the programmer on the ins without the antenna and reported that the issue was resolved.The patient was sent a replacement device.There were no symptoms reported.No complications or further complications were reported.
Additional Manufacturer Narrative
Corrected information: date of birth.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: 6538337
• Report Number: 2182208-2017-00689
• Device Sequence Number: 134302
• Product Code: MHY
• UDI-Device Identifier: 00613994691392
• UDI-Public: 00613994691392
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/02/2017

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: 06/28/2016
• Device Model Number: 37642
• Device Catalogue Number: 37642
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR