MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Unintended Collision (1429); Pocket Stimulation (1463); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Blurred Vision (2137); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 12/15/2016

Event Type  malfunction  

Event Description

The consumer reported the following change in therapy: shocking.It was stated when they were sitting, all of a sudden it felt like they were getting little shocks over the implantable neurostimulator (ins).It was noted it was random when they got shocked and wasn¿t related to any movement.It was indicated the patient had fallen, but they thought the shocks started before the falls.It was noted they weren¿t good at keeping track so it maybe in conjunction with the fall but wasn¿t sure.They hadn¿t had any recent medical test or exposure to an electromagnetic interference (emi) environment.The patient had an appointment with their managing doctor on (b)(6) 2017 and an appointment on (b)(6) 2017 with a doctor for their shoulder.It was also noted that their hand was shaking a little but stated they had always had it and didn¿t think it was related to the shocks.The patient was implanted for dystonia.

Event Description

Additional information was received from the patient¿s healthcare provider (hcp).It was reported that the patient¿s shoulder that is affected is not the one with the device implanted, so they are not related.It was also reported that the falls are not related.The patient¿s device was checked in the clinic.The hcp stated that the issues are not related to the patient¿s device.

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

The patient later reported that they feel the shocks in their eye when charging daily.Their eyes flutter, get shocked, and their vision blurs.It was noted the patient was going to see an eye doctor at the end of september about the blurred vision.The shocking lasts a bout a minute and then goes away.No further complications were reported.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6293880
• MDR Text Key: 66275345
• Report Number: 3004209178-2017-02291
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2017
• Date Device Manufactured: 08/26/2010
• 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: 56 YR