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

Model Number 37603

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Patient Device Interaction Problem (4001)

Patient Problem Electric Shock (2554)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 37603 lot# serial# (b)(4) implanted: (b)(6) 2019 explanted: product type implantable neurostim ulator if information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that starting around a year ago, the patient (pt) began to notice that if he turns to the right he will experience a series of electrical shocks that will eventually subside.It happens more often when he is in bed.Caller suggested it was not only this position but this was the position that was focused on during the call.The healthcare provider (hcp) has checked impedances 'throughout' her time working with pt and they have always been 'fine'.The caller states this started a year ago and agent asked if something prompted it like a fall and caller said the pt has been falling for some time (caller made it appear a normal situation for the pt) but did not attribute this shocking issue to a single fall or event.The caller states she ran impedance on right implanted neurostimulator (ins) and determined she was not concerned with the findings.Caller states she checked left ins therapy impedance when pt was just sitting in a chair--tested twice: 1) 664ohm 4.5ma 2) 718ohms 4.2ma.Caller then had pt turn head to the left and tested --652ohms 4.6ma.Then had pt turn head to the right and tested left ins twice-- 1) 718ohm 4.2ma 2) 692ohms 4.3ma.The caller states the shocking occurs in the face and his expression changes when it happens and she is unclear if that is related to anxiety or the movement of his face due to shock.Agent advised caller to consider imaging of system, reprogramming, evaluation of historical impedances, reviewed possible intermittent short (the caller mentioned while reviewing intermittent shorts that she had it 'happen in the past' but agent was not able to ask the caller about the details of that incident).Hcp was unable to determine the cause of the shocking.The patient would only experience the shocking in the supine position (laying down) and turning their head to the right.Other positions (i.E.Sitting up and turning their head to the left and/or right) did not produce shocking.Impedances were measured in various positions and there were no significant changes/concerns.She believes the shocking has subsided as the patient is avoiding turning their head to the right when laying down.The physician was unable to confirm which ins was related to the shocking.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11961697
• MDR Text Key: 267106851
• Report Number: 3004209178-2021-09022
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Date Device Manufactured: 03/05/2019
• 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: 61 YR
• Patient Weight: 91