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); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2016

Event Type  malfunction  

Event Description

A manufacturer representative (rep) reported a suspected overdischarge as of date notified.It was stated that the last successful recharge was (b)(6) 2016.One physician reset mode (prm) has been done by date notified, and during the call a second prm had been started with no response from the implantable neurostimulator (ins).Follow up with the healthcare provider (hcp) is to be conducted.The rep is to finish the second prm and see if the ins responds.On (b)(6) the rep met with the patient again to performed another prm.They were able to get 46 as a baseline and 60 when near the ins using the antenna locator feature.There was some difficulty finding the best antenna position as the ins is relatively superficial.A power on reset (por) message was then seen on the implantable neurostimulator recharger (insr) and a normal charging session was started with 4 coupling bars achieved.They will continue charging and clear the por.The patient's indication for implant is dystonia.

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: 6072844
• MDR Text Key: 59041669
• Report Number: 3004209178-2016-23064
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: 10/13/2016
• Supplement Dates FDA Received: 09/26/2017
• Date Device Manufactured: 04/26/2012
• 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: 67 YR