MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Device Displays Incorrect Message (2591); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Muscle Spasm(s) (1966); Anxiety (2328); Weight Changes (2607)

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37612, serial# (b)(4), implanted: (b)(6) 2016, product type: implantable neurostimulator.

Event Description

Information was received from a consumer regarding a patient with an implanted neurostimulator (ins) for dystonia and movement disorders.The caller reported that the patient has been experiencing poor coupling with both ins devices and were getting 0 coupling bars.The caller reported that performing an antenna locate and re-positioning the antenna over the ins resulted in 4 coupling bars which were lost shortly thereafter.The caller reported that on the right side the patient has only ever gotten 2-4 coupling bars and stated it had always been that way.The caller reported that the antenna locate resulted in the patient getting 2 coupling bars, but the recharger still showed the poor coupling screen.The caller confirmed that the ins was on.The caller reported that the patient had experienced weight gain, and that the patient's managing healthcare provider (hcp) stated that when they did the implant surgery, they did not place the implant battery correctly.The caller reported that the patient had a charley horse and that the patient was anxious.No further patient complications have been reported as a result of this event.[refer to manufacturer report #3004209178-2017-19093 for details pertaining to the reportable related event.].

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6855471
• MDR Text Key: 86576600
• Report Number: 3004209178-2017-19094
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• 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
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Date Device Manufactured: 04/25/2012
• 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