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

Model Number 37602

Device Problems Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37602, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.

Event Description

The patient reported via a manufacturer representative (rep) that when he moved the implantable neurostimulator (ins) around, he had tremors that get worse or better.This had occurred since implant.The rep noted that impedances were normal after a recent replacement.The rep met with the patient on (b)(6) 2016 and ran impedances on the left side, which was the side of the original issue.The range was 857 to 1,535 ohms.The patient told the rep that he did not think the right side was working at all.However, the rep turned stimulation off on that side and the tremors returned.This demonstrated that the therapy was working on that side and that there was symptom reduction of at least 50%, it just was not 100%.The patient thought the therapy was not as good as before.The right side impedances ranged from 359 to 1,786 ohms.The patient¿s indication(s) for use were essential tremor and movement disorders.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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 was feeling tingling sensation down face and left arm when moving right arm.It was reported that the manufacturer representative would be meeting with the patient and healthcare professional.It was noted that the impedance was fine at implant replacement surgery in early (b)(6) 2016.It was reported that the patient¿s therapy was not working as well since replacement surgery.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Follow up information received from the rep reported that they met with the patient and did not find anything unusual.It was stated that diagnostics were performed and found to be all within normal range.It was stated that the patient complained that the patient gets terrible tremors only when they move their hand a certain way.No actions/interventions were taken, and the rep thought therapy was working fine as the patient was doing fine.Furthermore, when the patient turned the device off their tremor would be terrible and they could not do without the device.The cause of the tremors was not determined, however, the patient was doing well since their last meeting with the patient advised to see the healthcare provider (hcp) if they thought something was not working.

Event Description

No new information received.

Manufacturer Narrative

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

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6192760
• MDR Text Key: 62924444
• Report Number: 3004209178-2016-26925
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/06/2017
• Date Device Manufactured: 07/21/2016
• 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: 71 YR
• Patient Weight: 104