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

Model Number 37603

Device Problem Energy Output Problem (1431)

Patient Problems Dysphagia/ Odynophagia (1815); Fatigue (1849); Muscle Weakness (1967); Therapeutic Effects, Unexpected (2099); Tingling (2171); Dizziness (2194); Dysphasia (2195); Complaint, Ill-Defined (2331); Malaise (2359); Neck Stiffness (2434); Shaking/Tremors (2515); Ambulation Difficulties (2544); Lethargy (2560); Alteration In Body Temperature (2682)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the patient has not had great improvement after the device implant.The patient has not been feeling well and their condition seemed to be worsening.When the patient turned on their device, they felt dizzy so they returned to the doctors for an appointment and had an adjustment which did not help the patient's symptoms.The patient felt sluggish.During the week, the patient would try to walk, however, they started to feel tired and had weak legs.During the second setting, the patient felt a rapid change; which included feeling a tingling in their nose, they also felt happier.However, after a few days the weakness returned and their voice began to decrease.The patient then had a third adjustment, which made them feel good for a few days but then days later had swallowing problems, lowering of voice volume, return of weakness again, and a change in body temperature but not a fever.The patient had to use a cane due to imbalance.In addition, the patient experienced heartburn and stomach pain, and it was described as "big stomach problems".Furthermore, the patient had left side tremors in both the arm and leg, and they touch their neck a lot as they felt stiff and dizzy, as well as had a wobble to their head.

• 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: 10458033
• MDR Text Key: 204526742
• Report Number: 3004209178-2020-14822
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000100353
• UDI-Public: 00763000100353
• Combination Product (y/n): N
• Reporter Country Code: RQ
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Date Device Manufactured: 01/17/2020
• 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