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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885)

Patient Problems Fever (1858); Shaking/Tremors (2515); Cognitive Changes (2551)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that implanted neurostimulator charge level was at 0.Patient (pt) has charged now to about 75% but pt is still tremoring.Caller states recharger icon is not showing the lightning bolt meaning ins off.Agent reviewed pt can be turned on with programmer, however, caller did not have programmer at time of call.Additional information received from the consumer reported the cause of the implant being at 0% was due to the device not being charged at all.The consumer noticed the issue because the patient was unable to participate in therapy as they were having tremors in their arms, legs, mouth, and head.The consumer put the recharger on the device and noticed the lightening bolt wasn't on so they started recharging and restarted the device with the programmer.The issue was then resolved.However, the consumer mentioned at that time the patient also had a fever and a possible infection and was started on antibiotics.Further follow-up was performed related to the antibiotics and possible infection.The consumer stated the patient did not have an infection at this point and the fever was determined to be a neurogenic fever and no antibiotics were taken for this.The patient developed delirium from everything they went through including chest pain from sepsis (which was unrelated to the dbs device/therapy), which resulted in the patient being admitted to the hospital for about a week and taking antibiotics and the device being off.The consumer believed the device being off contributed to the neurogenic fever and delirium.The device was turned back on, but the patient still had some delirium.

• 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: 11893135
• MDR Text Key: 252940713
• Report Number: 3004209178-2021-08432
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Date Device Manufactured: 08/22/2016
• 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): Other
• Patient Age: 75 YR