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

Model Number 37601

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problems Urinary Tract Infection (2120); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported that the patient had more tremors in the last 2 weeks and had a tendency to fall, sometimes 2-3 times a day with some of them noted as ¿quite heavy.¿ in addition, it was reported the patient could not connect with the implantable neurostimulator (ins) using the programmer unit.This issue was resolved when the antenna accessory was unplugged from the programmer (although it was noted that the connection also worked with the antenna plugged into the programmer).Follow up information received from the healthcare professional (hcp) on (b)(6) 2013 reported that cause of the event was likely urinary tract infection (uti), severe parkinson¿s disease, and sub optimal placement of the lead components of the ins system.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 64002, lot# n295393, implanted: (b)(6) 2012, product type: adapter.Product id: 3389-40, lot# l86128, implanted: (b)(6) 2000, product type: lead.Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2000, product type: extension.Product id: 3389-40, lot# l83842, implanted: (b)(6) 2000, product type: lead.Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2000, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

• 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: 3672833
• MDR Text Key: 4320106
• Report Number: 3004209178-2014-04222
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2013

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: 03/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2013
• Initial Date FDA Received: 03/11/2014
• Date Device Manufactured: 10/08/2011
• 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 Outcome(s): Required Intervention
• Patient Age: 00058 YR