MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number 37612

Device Problems Failure to Interrogate (1332); Energy Output Problem (1431); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problems Device Overstimulation of Tissue (1991); Shaking/Tremors (2515)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that patient wasn't able to get implant to charge; they could only get the reposition antenna screen. when patient tried connecting to implant with patient programmer they got poor communication so they couldn't turn their therapy on with the patient programmer.They said that normally when they turned therapy on they felt a rush that felt like them being electrocuted.  they haven't charged the implant in about a year because they had been in the hospital without their charging equipment.Patient was in the hospital because they had fallen in january, hit their head on the sidewalk, got a brain bleed and head trauma.Patient said that they want to use their deep brain stimulation therapy because they are real shaky now.It was reported that the patient cannot recharge ins.Technical services (ts) reviewed overdischarge scenario and how to perform physician mode recharge (pmr).Reviewed with the manufacturer representative (rep) if patient does not have recharging equipment, patient is likely in overdischarge.The rep will need to address replacement of equipment first as the patient cannot go home and recharge his implant once out of overdischarge.Ts reviewed how to start pmr and how to clear por.The rep stated the patient did not have access to recharger for 3-4 months.Additional information was received from the rep reporting he was able to successfully perform the pmr and get ins to recharging normally, however, he was unable to read with tablet.Ts reviewed the ins needs to be charged at least 25% in order to read with tablet.Rep asserted he did not charge beyond getting the ins out of overdischarge.We also discussed clearing the por on tablet.Rep plans on meeting patient again tomorrow to clear the por, due to office needed to close.Will request patient charge ins at home.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12514444
• MDR Text Key: 273340932
• Report Number: 3004209178-2021-14269
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/22/2021
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1