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

Model Number 37601

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neuro stimulator (ins) for movement disorders.It was reported that the patient shakes real bad, patient further stated that they would get programmed and therapy would work for a few days, and suddenly they would have the shakes again.This has been happening since implant.Patient reported that if they tried to adjust the left side, their therapy shuts off.Troubleshooting was done with patient programmer (pp), patient was at 1.40 on the left side, patient increased to 2.20, right side was at 2.10 and patient could not increase any higher.Patient synced with pp, and stimulation was on.It was noted that the health care professional (hcp) provided the patient ability to change amplitude or groups, and patient was able to adjust the left side from 1.40 to 2.20, patient tried to adjust the right side from 2.10 up but they were not able to increase, reporting a parameter limit symbol.Patient was redirected to follow up with hcp regarding symptoms.An email was sent to the manufacturer's representative (rep) fur further assistance.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient reporting that they were supposed to meet with a manufacturer representative (rep) today for programming, but they got a call from the doctor's office cancelling the appointment.The patient reported adjusting the left side from 1.40 to 2.20.The patient reported that their therapy would work for them once they were adjusted and then 2-3 days later they would get the shakes again.The patient called back on (b)(6) 2018 requesting a new patient programmer antenna.A replacement antenna was sent to the patient.No further patient complications have been reported as a result of this event.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7525552
• MDR Text Key: 108631226
• Report Number: 3004209178-2018-11236
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/16/2018
• Supplement Dates FDA Received: 05/29/2018
• Date Device Manufactured: 10/20/2017
• 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
• Patient Age: 63 YR