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

Model Number 37602

Device Problems Intermittent Continuity (1121); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant product(s): product id: 3387s-40, lot# v176477, implanted: (b)(6) 2009, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

A consumer reported they had a loss of therapy and therapy was intermittent and erratic.The patient wanted to know why their deep brain stimulation (dbs) was not working.The patient's indication for use is essential tremor and movement disorders.The patient had worked with a manufacturing representative multiple times and they kept trying to "regulate" and reprogram the implantable neurostimulator (ins).The patient would think the ins was fine, but two days after reprogramming the therapy would quit doing what it was supposed to and the patient would start shaking again.The problem started prior to the patient having their current ins implanted.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Event Description

Additional information received from a consumer reported the cause of the event was not known.There was no change in daily activity and the patient thought the device was on and presumed to be operating.The device was reset, but that did not seem to affect the patient's tremor.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5010677
• MDR Text Key: 24563098
• Report Number: 3004209178-2015-16194
• Device Sequence Number: 1
• Product Code: MHY
• 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
• Report Date: 07/23/2015

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: 08/14/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Date Device Manufactured: 02/14/2014
• 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: 00074 YR