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

Model Number 37601

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3389s-40, lot# va0b0kv, explanted: (b)(6) 2015, product type: lead; product id 3389s-40, lot# va09qwq, implanted: (b)(6) 2013, product type: lead; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.(b)(4).

Event Description

A health care provider (hcp) reported via a manufacturing representative that the patient's right lead was removed due to infection.The hcp suspected the patient's shoulder surgeries may have led to the infection.During the lead removal, the extension was cut and a portion of the extension was left implanted.The remaining portion of the extension was to be removed when the new lead and extension were implanted.A surgery date for the implant of the new lead and extension had not been set.The issue was not resolved at the time of this report.The patient was alive with no injury at the time of this report.The patient's indication for use is parkinson's dual and movement disorders.No outcome was 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.

Event Description

Additional information received from a manufacturing representative reported the patient had a complete system explant due to infection.The patient铠health care provider (hcp) believed the cause of the infection was shoulder surgeries.The patient planned to be reimplanted once they were free of the infection.

• 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: 5189184
• MDR Text Key: 29914044
• Report Number: 3004209178-2015-21844
• 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
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Date Device Manufactured: 06/04/2013
• 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: 00062 YR