MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id 37603, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 37603, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 3389s-40, lot# v742349, implanted: (b)(6) 2011, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 3389s-40, lot# v761178, product type: lead.(b)(4).

Event Description

A health care provider (hcp) reported that an unknown error code was displayed.Early last week, the patient met with a manufacturing representative for interrogation of the implantable neurostimulators (ins).The manufacturing representative saw a "call your doctor" icon at that time.The ins's were on, but they would need to be replaced soon.The patient believed the inss still were not working.Recently the patient had been transferred to a hospital for rehabilitation.The patient's indication for use is parkinson's dual and movement disorders.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5034897
• MDR Text Key: 26231584
• Report Number: 3004209178-2015-16818
• Device Sequence Number: 1
• Product Code: MHY
• 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: health professional
• Reporter Occupation: Health Professional
• Report Date: 08/06/2015

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: 10/28/2012
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Date Device Manufactured: 05/03/2011
• 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: 00062 YR