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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that the patient had their deep brain stimulator installed in 2012 and after discovering an exposed wire had the present unit installed on (b)(6) 2013.The patient¿s neck had been bothering him for a couple of months so the healthcare professional had checked it and discovered the wire was exposed.The exposed wire was discovered 8 months after implant.A replacement was done on (b)(6) 2013.They had to rewire everything and the healthcare professional was playing it safe because they were afraid there might be an infection.No infection was reported that was just the reasoning for doing everything except the leads.The patient¿s last visit to the healthcare professional was on (b)(6) 2013 and they had not followed up with the patient since the event.The patient had not had concerns with their device or therapy.

Manufacturer Narrative

Concomitant medical products: product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 3389s-40, lot# va01lp5, implanted: (b)(6) 2012, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension; product id 3708660, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: extension.(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: 4526333
• MDR Text Key: 5492034
• Report Number: 3004209178-2015-03275
• 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: Other
• Type of Report: Initial
• Report Date: 01/29/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/19/2015
• Date Device Manufactured: 06/29/2012
• 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: 00071 YR