MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problems Electromagnetic Interference (1194); Loss of Data (2903)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

Product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3389s-40, lot# va0pdv4, implanted: (b)(6) 2015, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer.Patient product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3389s-40, lot# va0rr28, implanted: (b)(6) 2015, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).

Event Description

It was reported the patient had a standing x-ray a month prior to report and the x-ray was up right against the patientimplant.The patient might have been affected by it.The patient had a return of symptoms.They went to their health care professional (hcp) to get reprogrammed and initially the hcp had trouble and that is why they thought the patientdevice might have reset.They didnuse the programmer to check the patientimplant after the x-ray incident.Please see manufacturer report #3004209178-2015-12900 for information on the patient's concomitant system.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 4895834
• MDR Text Key: 24557758
• Report Number: 3004209178-2015-12901
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/07/2015
• Date Device Manufactured: 12/02/2014
• 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: 00016 YR