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

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950)

Patient Problems Hearing Impairment (1881); Neurological Deficit/Dysfunction (1982); Pain (1994); Complaint, Ill-Defined (2331); Dyskinesia (2363); Neck Stiffness (2434); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va1ahh0, implanted: (b)(6) 2016, product type: lead.Product id 3708660, serial# (b)(4), implanted: (b)(6) 2016, product type: extension.Product id 3708660, serial# (b)(4), implanted: (b)(6) 2016, product type: extension.Information references the main component of the system.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 3389s-40, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: (b)(6) 2020, udi#: (b)(4).Applies to the implantable neurostimulator (serial #(b)(4)) and leads (lot # va1ahh0) fdc applies to the extensions (serial # (b)(4)).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient with an im plantable neurostimulator (ins) for the treatment of parkinson's disease and movement disorders.It was reported beginning (b)(6) 2018 after a very loud party/loud music the patient woke up in the middle of the night, turned from her right side to her left side and heard a sizzling/static sound "like you would hear from a speaker or sound system" in her right hear that lasted for a few seconds and then spontaneously resolved.She heard it again the evening of (b)(6) 2018.No other symptoms or pain were reported.Since then, it had been occurring unpredictably throughout the day approximately 4-6 times a day and it seemed to be increasing in frequency since the weekend prior when it first began.It was reported it seemed to occur more when lying in bed turning from right to her left side but it also occurred during the day.The patient contacted their hcp on (b)(6) 2018 stating she felt electrical zaps for a few seconds on her right ear and it was happening intermittently.The patient went to the audiologist on (b)(6) 2018 and the patient was told she had some mild hearing deficits at higher frequencies.She was doing well in terms of her parkinson's symptoms.Impedance check on (b)(6) 2018 with the neck in various positions did not show any system issue.Skull and chest x-rays and palpation also did not show any problems, breakages or kinks in the wiring.It was reported the evaluation was unremarkable.It was unknown if the patient had any ear implants.During the appointed the patient experienced the sound once and it only lasted for a few seconds after which it spontaneously resolved.The rep could not hear the sound, only the patient.Therapy impedances during the appointment were: group b (active) left: c+2- 2.3 v 120 us 100 hz; 1039 ohms, 2.205 ma right: c+10- 1.5 v 60 us 100 hz; 920 ohms, 1.649 ma the rep checked the therapy impedances a second and third time with similar results.This was similar to the therapy impedances at the end of her last visit on (b)(6) 2018.Impedance testing during the appointment showed: left: at 0.7 v all values were within normal limits.The patient moved her neck around and c & 0 was slightly elevated (2004 ohms) which normalized/reduced to 1496 ohms at 1.5v.Right: at 0.7 v all values were within normal limits even when moving her neck.It was noted the patient increased left voltage from 2.0 to 2.3 v on (b)(6) 2018 to control her right sided symptoms.During the exam the hcp noted they could see the wire in the right side of the neck with mild evidence of pulling.The patient reported some intermittent pulling of the wire in the right side of the neck but denied any pain along the course of the wire.It was noted the patient had stage 3 parkinson's disease complicated by tremor, on state dyskinesia, painful dystonia.The patient was not reprogrammed during the session and was scheduled to return to the clinic (b)(6).No further complications were reported or anticipated.

• Brand Name: ACTIVA
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7494140
• MDR Text Key: 107586512
• Report Number: 3004209178-2018-10339
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/08/2018
• Date Device Manufactured: 09/29/2016
• 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 Age: 45 YR