MAUDE Adverse Event Report: MEDTRONIC, INC. RESTORE SENSOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	37754
Medical Device Problem Codes	Use of Device Problem (1670); Charging Problem (2892); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sometimes the ins batteries cause interference with each other during ins recharge sessions.The caller explained that the ins batteries were implanted in the patient's abdomen and are located close to each other.The caller stated that sometimes the ins recharge session will be "good," but sometimes "funky error messages" appear on the recharger related case (b)(4).However, the caller confirmed the patient was able to resolve the issue by repositioning the recharger antenna and trying again.The caller did not specify the error messages that appeared on the recharger.The caller indicated that the patient became used to the ins batteries interfering with each other during ins recharge sessions.No symptoms were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE SENSOR
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12857180
• Report Number: 2182208-2021-04579
• Device Sequence Number: 14473469
• Product Code: MHY
• UDI-Device Identifier: 00643169119215
• UDI-Public: 00643169119215
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 11/22/2021

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: 37754
• Device Catalogue Number: 37754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/22/2021
• Date Device Manufactured: 03/14/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female