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

Model Number 37612

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

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 a neurostimulator (ins) for an unknown dbs therapy.It was reported that the patient's son was calling and they said that the device was not working.Patient services asked the caller meant the insr or the patient programmer (pp).Caller confirmed it was the patient programmer that was not working.Caller stated that the problem had been going on for about two weeks.Patient services asked the caller meant the pp was not powering on.Caller stated the pp powered on.Patient services had the caller connect the pp with the ins to better explain what the issue was.Patient services reviewed how to properly sync the pp with the ins.Caller reported that they were successful with syncing and saw that it was on.Patient was at 2.40 "a" 2.70.Caller reported that the patient didn't feel that their therapy was successful.Caller inquired about how high to increase stimulation.It was reviewed that the hcp offers directions on making adjustments to the settings.Caller stated they wanted to know how to increase it.Patient services reviewed the role of ps, but provided steps on how to increase.Caller asked how high they should increase the stimulation, and reported that previously with the hcp they increased stimulation and it "wasn't good" for the patient because the patient was "too energetic." patient services reviewed that they could not offer recommendations on how high to increase stimulation because they were not the hcp.Caller on their own increased the stimulation from 2.40 to 2.60.Patient services encouraged the patient to follow up with the hcp.They stated that they see the hcp on the 21st of the month.There were on further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare provider (hcp) reported the patient was seen on (b)(6) 2018 and was doing well on their current settings so no adjustments were made.The cause of the device not working, therapy not being successful, and being ¿too energetic¿ when stimulation was increased was not determined but had been resolved.No further complications were anticipated.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received: it was reported that the patient said they were calling about the same thing as before, and said they just saw the doctor and they wanted them to "go through using it one more time, they said everything was ok at the office" when they went to see the doctor.Patient services reviewed how to check the settings and it had shown that the ins was low and the ins needed to be charged.Patient services then had them get out their insr and they reported getting 8 coupling bars filled in.They were advised to charge the device and to call back if they needed help with the programmer.There were no further complications reported.

• 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: 7591574
• MDR Text Key: 110784017
• Report Number: 3004209178-2018-13180
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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,Followup,Followup,Followup
• Report Date: 10/05/2018

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: 06/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 06/08/2018; 06/25/2018; 06/25/2018; 07/30/2018; 08/08/2018
• Supplement Dates FDA Received: 06/12/2018; 07/11/2018; 07/12/2018; 08/13/2018; 10/05/2018
• Date Device Manufactured: 08/12/2016
• 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: 59 YR
• Patient Weight: 101