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

Model Number 7428

Device Problems Device Or Device Fragments Location Unknown (2590); Malposition of Device (2616)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/04/2009

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3389-40, lot# v004936, implanted: (b)(6) 2006, product type: lead.Product id: 3389-40, lot# v004137, implanted: (b)(6) 2006, product type: lead.Product id: 7436, serial# (b)(4), implanted: (b)(6) 2006, product type: programmer, patient.Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2009, product type: extension.Product id: 3389-40, lot# v004936, implanted: (b)(6) 2006, product type: lead.Product id: 3389-40, lot# v004137, implanted: (b)(6) 2006, product type: lead.Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.(b)(4).

Event Description

A consume reported the patient's deep brain stimulation (dbs) system was now inactive.The surgery never worked for the patient and the surgeon placed the wires in the wrong place.The patient went through four more surgeries that were all unsuccessful.The reporter believed the surgery would have been successful had they gone to another health care provider (hcp).The reporter was not sure if it was something with the hcp or the device.The patient's indication for use is parkinson's dual.No interventions or outcome were 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.

• Brand Name: KINETRA
• 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: 5021582
• MDR Text Key: 23707817
• Report Number: 3004209178-2015-16463
• 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
• Reporter Occupation: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2010
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2015
• Date Device Manufactured: 02/23/2009
• 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: 00067 YR