MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Failure to Interrogate (1332); No Device Output (1435); Insufficient Information (3190)

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

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37092, serial #: unknown, product type: accessory.Other relevant device(s) are: product id: 37092, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for essential tremor and movement disorders.It was reported the patient programmer was not working.The patient programmer was not powering on and they clarified there was a poor communication screen with the antenna plugged in.They turn the ins off at night and turn it back on in the morning, lately, they cannot do that.The patient changed the patient programmer four times and it did not help in resolving the issue.The poor communication has not resolved.When the patient disconnected the antenna from the patient programmer they were able to sync with the ins.They then tried to use the patient programmer again and they were seeing the poor communication screen.No patient symptoms or further complications were reported as a result of this event.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 8335349
• MDR Text Key: 137558062
• Report Number: 3004209178-2019-03047
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2019
• Date Device Manufactured: 06/15/2016
• 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: 80 YR