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

Model Number 7428

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that there was an infection.The implantable neurostimulator (ins) was taken out due to the infection a few years prior to the lead being removed in 2010.The patient had gotten a mosquito bite near the lead wire connection and the patient had scratched it and then puss was present.The lead wire was also removed due to an infection.The deep brain stimulator was not working correctly and was shut off due to infection in 2010.Part but not the whole system was removed in 2010.It was noted that the patient had no active devices at the time of this report.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Concomitant products: product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension.Product id: 7436, serial# (b)(4), implanted: (b)(6) 2004, product type: programmer, patient.Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension.Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead.Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead.Product id: 3387-40, lot# j0343991v, implanted: (b)(6) 2004, product type: lead.(b)(4).

• 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: 4866430
• MDR Text Key: 18716829
• Report Number: 3004209178-2015-12160
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2007
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2015
• Date Device Manufactured: 01/23/2006
• 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