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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Memory Loss/Impairment (1958); Visual Disturbances (2140); Dysphasia (2195); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 04/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the patient had bilateral deep brain stimulation (dbs) removed in 2020.However, there was conflicting information as they stated the original chest implant was replaced in 2015 and the dates they provided were their best guess without looking at the patient's records.The patient suffered severe mental and physical disability.They indicated the patient's outcome was hospitalization and disability/permanent damage.The patient went from being somewhat independent (able to drive, walk, talk, get groceries) to needing full medical care, affected speech, legs, arms, memory, cognitive thinking, eyes, sleep, and sanity (the patient was walking around naked in their apartment building).The patient's treatment is over a long period.The patient had the original device placed in 2010.They were told the dbs would work and this also happened in 2015 with the original chest implant being replaced.The patient had a second implant in 2015 and was seen by a neurologist who tampered with the device / "adjusted settings" from 2018-2020.The patient has improved significantly since the removal and they have proof the device was the issue.They have been told that the dbs was not the problem or to try a new setting on the device, which has been devastating to the patient's life.They stated the dbs is known to cause problems, mental side effects, and physical problems.They believe the devices were returned to the manufacturer.The patient takes senna and one-a-day 50+ multivitamin.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10900525
• MDR Text Key: 218218227
• Report Number: 3004209178-2020-20591
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2020
• Date Device Manufactured: 04/08/2015
• 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 Outcome(s): Hospitalization; Disability
• Patient Age: 64 YR