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

Model Number 37612

Device Problems Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

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

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

Note that section d information references the main component of the system and other applicable components are: product id 37642 lot# serial# (b)(4 implanted: explanted: product type programmer, patient.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer via a manufacturer representative reported a communication failure that occurred for the patient programmer; there was an unknown indication/error displayed.The consumer was implanted on both sides and when the patient programmer was attempted to communicate with the left-side device only there was an indication displayed.The devices were charged.There was no particular factors noted to have led to the event.After communicating with the device using a clinician programmer, communicating with the patient programmer was back to normal.The issue was noted as resolved.Additional information received reported the consumer was scheduled for an outpatient follow-up visit on (b)(6) 2017 and (b)(6) 2017.The consumer requested explanation of the cause of the reported issue.Further information indicated that the consumer reported the alert functions should have been turned off, but actually the alert functions were on.As the alert functions worked at 11:00 am, the alert functions seemingly reprogrammed to the original settings.The consumer¿s underlying disease was dystonia.Additional information was received from the representative and it was reviewed that the error displayed was the ¿ins in the box¿ screen.It was reviewed the issue that likely occurred is a known issue associated with the use of the antenna locate feature and to prevent the issue the consumer should not use the antenna locate feature and/or wait at least 10 seconds between ending the antenna locate feature and starting a charge session.When the issue occurs use of the clinician programmer reprograms the bit and resolves the issue.

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; 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6230762
• MDR Text Key: 64089698
• Report Number: 3004209178-2017-00407
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2013
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Date Device Manufactured: 05/25/2012
• 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