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

Model Number 37603

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

Patient Problem Unspecified Infection (1930)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: extension.Product id: 3387s-40, lot# v902308, implanted: (b)(6) 2012, explanted: (b)(6) 2015, product type: lead.Product id: 37085-40, serial# (b)(4), implanted: (b)(6)2012, product type: extension.Product id: 3387s-40, lot# v688050, implanted: (b)(6) 2012, product type: lead.Product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.(b)(4).

Event Description

A healthcare professional reported that on (b)(6) 2015 there was an infection at the stimlock and on (b)(6) 2015 there was an explant.It was unknown what had led to the event.A culture was taken.The issue was resolved.

• 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: 5026115
• MDR Text Key: 23907337
• Report Number: 3004209178-2015-16540
• 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: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2015
• Date Device Manufactured: 01/25/2012
• 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: 00072 YR