MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37602

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

Patient Problems Fall (1848); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Tachycardia (2095); Cognitive Changes (2551)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for parkinsons and deep brain stimulation therapy indications.It was reported that the patient has fallen 3 times recently and now they are "getting delirious and confused and stuff like that." the caller stated that the patient has been falling for years, but just recently they started "back falling." the caller added that the patient has been very weak and on february 21st their blood pressure was 162/90 and their pulse was 122.Before calling, the caller stated that they checked the patient's  implanted neurostimulator (ins) with the patient programmer and confirmed that the ins is on and is set to "3.70." the patient was redirected to their healthcare provider to further address the issue.

• Brand Name: ACTIVA
• 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: 11406382
• MDR Text Key: 234510208
• Report Number: 3004209178-2021-03623
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761057
• UDI-Public: 00613994761057
• 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
• Type of Report: Initial
• Report Date: 03/03/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/03/2021
• Date Device Manufactured: 03/05/2018
• 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