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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Insufficient Information (3190)

Patient Problems Cognitive Changes (2551); Suicidal Ideation (4429)

Event Date 01/04/2022

Event Type  Injury  

Event Description

It was reported that the patient was needing a new recharger that was lost while the patient was in the emergency room (er).With follow up at the psychiatric hospital where the patient was discharged, the staff stated the patient was in the er for "psychiatric issues involving suicide ideation" and further stated he was not sure his dbs was working either.The er deemed the patient need to be transferred to psychiatric hospital for further treatment.Replacements were sent and received on (b)(6).It is unknown if there were any factors that may have led or contributed to the issue.The manufacturer representative (rep) saw the patient at the psychiatric hospital on (b)(6) 2022, helped set up the new recharger unit, and worked with him and the staff on how to use it.He charged a short while then turned his dbs system on using a patient programmer, which had gone off due to low battery, then he settled in for a long charging session.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.It is unknown but not anticipated by the nurse practitioner (np) that the issue was related to the device.Per np the cause of the issue was the patient having a long history of mental illness.Actions and interventions include the patient being placed in a psychiatric hospital.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13232175
• MDR Text Key: 284376911
• Report Number: 3004209178-2022-00496
• Device Sequence Number: 1
• Product Code: PJS
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Date Device Manufactured: 12/10/2020
• 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
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 125 KG