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

Model Number 37601

Device Problems Break (1069); High impedance (1291); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2024

Event Type  Injury  

Event Description

It was reported that the system connectivity test failed and all symptoms of the patient's parkinson's disease (pd) are back on this side.A contributing factor is that the extension was exposed following the explant of the depleted stimulator and the extensions were covered in boots and placed in the device pocket couple of weeks prior to the event, as there was no replacement device at the time.On (b)(6) 2024, the new device was implanted, and upon connection the connectivity test showed that one side has impedance above 40,000 ohms and connectivity test failed. a connectivity test, impedance test, and therapy impedance test were run, the port was switched at the extension/electrode level, and all tests were repeated. the port was switched at the extension/neurostimulator level, cleaned with an alcohol swab, sterile drying of the extension/stimulator level, visual inspection at all accessible levels, and x-rays were taken. upon switching ports, the same issue occurred on-contralateral side which means one side has open circuit.A visual inspection of the extension showed the seal between electrode and extension port was not heretically sealed and blood and cellular fluid leaked inside.X-ray in anterior-posterior and side projection were completed to verify the integrity of the electrodes and extension with non-conclusive results.There is a possible fracture near the extension port.However, since the seal was broken and components appear to be filled with red fluid - this was not a main culprit.System was connected but affected side was disable via software programming until replacement parts will reach the hospital for an exchange.

Manufacturer Narrative

Section d information references the main component of the system.Other relevant device(s) are: product id: 3708640, serial/lot #: (b)(6), ubd: 18-jan-2027, udi#: (b)(4); product id: neu_unknown_lead, serial/lot #: unknown, ubd: 18-jan-2027.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 19124115
• MDR Text Key: 340353129
• Report Number: 3004209178-2024-09211
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: KZ
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Date Device Manufactured: 04/12/2023
• 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): Required Intervention
• Patient Sex: Female