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

Model Number 37602

Device Problems Energy Output Problem (1431); Device Difficult to Program or Calibrate (1496); Electromagnetic Compatibility Problem (2927)

Patient Problems Fall (1848); Fatigue (1849); Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 05/24/2018

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 neurostimulator (ins) for essential tremor and movement disorders.It was reported that patient has two implants one in each chest and was having problems with getting them set or programmed properly.Patient stated that the programming did not seem to be holding.Patient goes to the neurologist and he sets the programming and it seems to be fine it stops the tremor and then within a couple days it suddenly returns.Patient stated that they were at the at the neurologist yesterday and was reprogrammed and was fine, and today patient was having difficulties with the tremors.Patient noted that they had one device for the right side and it helped.They added second device in (b)(6) 2018 and now is having trouble with tremors on both sides.Patient was informed that the ins's are designed not to talk to each other, so they can't sense anything the other side is doing, and that patient might not be at their therapeutic level yet.Patient was advised to contact their doctor and review their case.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

Information was received from a consumer.The patient reported for about two months prior he was having difficulty having the implants programmed correctly.The patient stated his tremor had gotten worse and the rep came in to reprogram the devices but that didn't resolve anything.The patient stated he ended up in the er on (b)(6) 2019 for different non-device related issues but his tremors did come up at the er.The patient stated the health care professional (hcp) recommended he go see a neurologist to have the deep brain stimulation (dbs) programmed.The patient stated he needed to see an hcp to troubleshoot the programming and actually look at the devices to see if they were implanted correctly.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer reporting that they are frustrated with the implants and can't seem to get them to work.They explained they have been to their neurologist almost every week to get the devices adjusted to get shakes to go away, but they have gotten worse.The patient added that it wears them out walking from one room to another and that he's had to quit work because of his tremors.The patient was trying to get into a hospital but said "they don't know if they can make it till then" with an opening in september.They state they have been seen by a manufacturer representative.The patient was asked if they had any falls or trauma and confirmed they feel once "probably in may" because he was shaking while walking.The patient added that it resulted in just a minor facial scrape and stuff like that.They went in for a check up after the fall.The system was not assessed at the time.After the fall, the rep hooked up the implants, checked the leads, and said "everything was good".The rep was not aware of the fall.They loved the device for 10 years, noting that it took away the tremors.The "other side" went bad so they had an implant put in last year to control the other side.They noted they have not been able to get the most recent device implant under control.

• 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: 8390149
• MDR Text Key: 137849845
• Report Number: 3004209178-2019-04477
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761064
• UDI-Public: 00613994761064
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

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: 08/14/2018
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 04/16/2019; 07/01/2019
• Supplement Dates FDA Received: 04/19/2019; 07/10/2019
• Date Device Manufactured: 02/16/2017
• 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: 64 YR