MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Break (1069); Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)

Patient Problems Dyskinesia (2363); Ambulation Difficulties (2544); Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 7482a-51, serial/lot #: unknown,product id: 7428, serial/lot #: unknown.Please note that this date is based off the date that the article was accepted for publication as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Kiss zht, bruno va.Letter to editor in response to de vloo et al.: open fracture of dbs leads with normal electrical impedance.Brain stimul.2020;13(6):1687-1688.10.1016/j.Brs.2020.09.014.Reported events: it was reported that the patient had shocks in their head/neck with spontanious neck movements.Impedance measurements were normal.Imaging of the device revealed an apprent wire disconnection inside the extension.The extension was explanted, and it was found the extension was physically intact but the inside of the insulation the wiring was pale and seemingly lost its coil.The extension was replaced.The patient's symptoms included gait issues and dyskinesia.It was reported that the patient underwent an ins replacement after a lightning strike in 2004.It was not possible to ascertain specific device information from the article or to match the reported event with any previously reported event.See attached literature article.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11096228
• MDR Text Key: 227882726
• Report Number: 2182207-2020-01575
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/30/2020

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 Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• 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): Required Intervention
• Patient Age: 64 YR