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

Model Number 37603

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 02/13/2018

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 essential tremor and movement disorders.It was reported that patient has the device for essential tremor in the right hand.Patient stated that they did conform the device was turned on and they had been to the doctor may times.Patient stated they had an mri and was told it showed everything was in the right place.Patient stated that the doctor had adjusted it, and for a few seconds it might be good , then it goes back to normal.The patient noted that they were not getting any results from the managing doctor as she won't help them.Patient stated their next appointment was in (b)(6).Patient wanted a local manufacturer's representative (rep) and have the device checked.It was reviewed that the patient can only be seen at the doctor's office.Patient reported that the their right hand shakes worse than the left hand and they could hardly eat.Patient reported that their system was not working right, and needs the manufacturer to figure out what was wrong.An email was sent out to the rep.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 consumer stating the system not working was first noticed in (b)(6) 2017.The patient reported they underwent a procedure on (b)(6) 2015 (registration records indicate it was (b)(6) 2018.It was reported the system started out great and slowly reversed.The patient had been to the neurologist several times and they could not write, eat, etc.A new battery was installed in (b)(6) 2018 (registration records indicate it was (b)(6) 2018) but it didn¿t change.It was reported the system not working and the shaking had not been resolved at the time of the report.(b)(4).

• 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: 7596357
• MDR Text Key: 111025580
• Report Number: 3004209178-2018-13292
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• 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: 06/29/2018

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: 06/14/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 06/29/2018
• Date Device Manufactured: 12/15/2017
• 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: 79 YR
• Patient Weight: 77