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

Model Number 37601

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Neurological Deficit/Dysfunction (1982); Shaking/Tremors (2515)

Event Date 03/12/2018

Event Type  Injury  

Manufacturer Narrative

Medical devices: product id 3389-28, lot# 0208388592, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type lead.Product id 3389-28, lot# 0208391195, implanted: (b)(6) 2014, product type lead.Product id neu_unknown_ext, explanted: (b)(6) 2018, product type extension.Product id neu_unknown_ext, implanted: (b)(6) 2014, product type extension.Information references the main component of the system.Other relevant device(s) are: product id: 3389-28, serial/lot #: (b)(4), ubd: 09-may-2018, udi#: (b)(4); product id: neu_unknown_ext, ubd: 09-may-2018, (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) of a clinical study via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for unknown indications for use.The right lead and extension were explanted and replaced due to lead migration/dislodgement which led to intolerable left side akinesia and tremor.Diagnostic methods included imaging on (b)(6) 2018 which confirmed right lead migration.The etiology was described as related to device/therapy and procedure.The event resulted in in-patient or prolonged hospitalization and medical/surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.The last system modification was on (b)(6) 2018.The event was resolved without sequelae on (b)(6) 2018.No further complications are anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.The clinical diagnosis was updated to parkinson's disease symptoms reappearing due to lead migration.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received noted that the patient's clinical diagnosis was parkinson's disease.

• 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: 7732103
• MDR Text Key: 115416022
• Report Number: 3004209178-2018-16939
• Device Sequence Number: 0
• Product Code: MHY
• Reporter Country Code: FR
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 10/23/2017
• 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): Hospitalization; Required Intervention
• Patient Weight: 87