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

Model Number 37612

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Date 01/01/2013

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are : product id 37601, serial # (b)(4), implanted: (b)(6) 2011, product type implantable neurostimulator.

Event Description

The healthcare professional (hcp) of a clinical study reported that there was an alleged overdischarge.The implantable neurostimulator (ins) had not been used for 2 years.Communication could not be established with the patient programmer, implantable neurostimulator recharger (insr), and physician programmer.The last successful recharging session was 2 years prior to report.The patient had 2 gpi placements with the rechargeable ins.The patient stopped using the implantable neurostimulator (ins) many years ago because therapy was not working for the patient and it was causing too many side effects.The patient also had a primary cell device with 2 leads in stn that they were able to turn on the day of report.The patient stopped using the primary cell device for unknown reasons.The patient and family have no inclination to use either battery at the time of report.The cause of the therapy not working and side effects were not determined.It was unknown what diagnostic were performed related to the therapy not working and the side effects.Relevant medical history included: dystonia, movement disorders.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6181747
• MDR Text Key: 62707366
• Report Number: 3004209178-2016-26647
• Device Sequence Number: 1
• Product Code: MRU
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2016

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: 03/14/2013
• 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: 11/22/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: 11/22/2016
• Supplement Dates FDA Received: 09/28/2017
• Date Device Manufactured: 04/18/2012
• 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
• Patient Age: 49 YR