MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION GENERATOR, DBS DUAL CHANNEL ACTIVA PC SNKM723187H; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Failure of Implant (1924); Shaking/Tremors (2515)

Event Date 06/24/2021

Event Type  Injury  

Event Description

Prior to (b)(6) 2021 the battery checker read 3.30 and 3.80, seen neurologist on (b)(6) 2021 he states he was just deleting old settings see medical record all documented/recorded for referencing dr states battery is good so does other 2 people in room, deleted old settings but everything checks out, in 13 days the battery depleted, have pics, never could change settings myself (documented) tremors seem to worsen checked the battery it was at 7.90 and 9.00 as the battery checker stated we have never changed settings or changed settings as we have never had to the checker has always been on 3.30 and 3.80 when checked as i documented everything.Tremors worsened and on (b)(6) 2021 the eri light came on.A medtronic rep interrogated the system and had to put it back to 3.30 3.80 explaining that they can only use the settings programmed by the clinician.The battery worked fine until (b)(6) 2021 mid evening the tremors seem to pick up contacted the clinic.On (b)(6) 2021 the hospital put a new battery in a percept pc different setup from before but now this one seems to create more tremoring can't check the settings in percept pc as documented by medtronic, also a representative also came out and a staff member made a recording on how to check it if needed as the rep stated.The 7.90 and 9.00 setting should not be used.Also the percept pc needs to be addressed.Have videos, records, logs, all documented.Contact with the (b)(6) (mdhhs also viewed documentation from medtronic) contacted medtronic documented stating not mri mode.Ipg is implanted only have pic of dbs checker settings, never changed, documented only a physician can change settings.Prior to appt a medtronic rep stated a different mode but i called medtronic headquarters and they gave me documented confirmation that the rep was wrong.New ipg doesn't work like other one.Fda safety report id# (b)(4).

• Brand Name: GENERATOR, DBS DUAL CHANNEL ACTIVA PC SNKM723187H
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 14593501
• MDR Text Key: 293379923
• Report Number: MW5110087
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/31/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37601
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CARBIDOPA LEVODOPA 25/100; DEEP BRAIN STIMULATOR WITH ; MELATONIN; PERCEPT PC GENERATOR
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian