MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Complaint, Ill-Defined (2331)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Medical devices: product id 37603, serial# (b)(4), implanted: (b)(6) 2015, product type implantable neurostimulator.

Event Description

Information was received from a consumer and health care provider (hcp) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported the patient was struggling with their right arm as of the day prior to this report.The issue started and got better, but it was worse now.It was noted the left ins controls the right side.It was stated a nurse checked the ins batteries and the right ins connected, but there was poor communication with the left ins.The consumer wondered if that meant the ins was dead because the patient has high settings and an health care provider (hcp) stated the inss would be depleting soon.Additional information was received from the nurse.It was reported that the left ins connected fine, but there was poor communication with the right ins.This contradicts the previous report that the left ins had poor communication.The issue was resolved while trying to re-connect with the ins.The ins displayed ¿ok¿.It was noted the patient had poor tone and more stiffness the day prior to this report and the day of this report.It was also noted that it could be due to the cold, but this was not known for certain.No further complications were reported.Refer to manufacturer report # 3004209178-2017-25865 for details pertaining to the reportable related event.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 7109881
• MDR Text Key: 95737169
• Report Number: 3004209178-2017-25866
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2017
• Date Device Manufactured: 08/20/2015
• 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: 12 YR