MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PERCEPT; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number B35200

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

After battery replacement from activa pc to percept pc on (b)(6) 2023, patient reported therapy not controlling symptoms as well.Provider thought it was due to the change from voltage to constant current.Patient was reprogrammed many times to try and control symptoms.Symptoms were controlled but not as much as before with activa pc.Patient reported feeling some shocking feelings by the pocket but did not make that known to providers until recently.Patient met with neurosurgeon and surgeon decided to proceed with replacing extensions and generator to ease patient of shocking sensation.Unable to visually examine any defects on the extensions or within the generator.Impedances always reported as normal.The issue resolved after replacement.

• Brand Name: PERCEPT
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18999558
• MDR Text Key: 338876051
• Report Number: 3004209178-2024-07973
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000642174
• UDI-Public: 00763000642174
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2024
• Date Device Manufactured: 06/28/2023
• 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 Age: 64 YR
• Patient Sex: Female