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

Model Number 37601

Device Problems Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3 708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3389s-40, lot# v937755v01, implanted: (b)(6) 2014, product type: lead.Product id: 3389s-40, lot# va0j0kk, implanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

A health care provider reported via a manufacturing representative that the patient had a shocking sensation in their chest wall area.The patient's indication for use is parkinson's dual and movement disorders.The issue was identified through normal stimulation.X-rays were done and the neurosurgeon found no obvious defects.No additional intervention was done and the issue was not resolved at the time of this report.An appointment for the patient's device to be evaluated by a manufacturing representative was scheduled for within the next two weeks.A manufacturing representative reported a week later that the patient had no shocking coming from the implantable neurostimulator (ins) site.The patient had pain that was radiating from their neck down their arm.The neurosurgeon was going to evaluate the patient for cervical neck issue.The manufacturing representative stated there was no product concern.

• 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 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: 5035027
• MDR Text Key: 25888849
• Report Number: 3004209178-2015-16824
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2015
• Date Device Manufactured: 02/11/2014
• 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: 00074 YR