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 Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient¿s therapy wasn¿t as good as it used to be.The patient noticed this change a couple of years ago.The patient had a hard time walking and his hands shake more.His head was shaking but not as bad as it was prior to implant.The patient had set up appointments in the past, but never went to them.The patient had a follow up appointment on (b)(6) 2013.There was also a problem with the patient programmer.It had last worked a week prior.It was later reported when the patient had first had the device put in they had had a problem with the top of their head.The patient could feel electricity when they put it on but that had gone away.The patient had tremor.The patient had felt great after the first operation but now had not, the patient still could not write and had been shaking ever since she was young.It was unknown when the implantable neurostimulator (ins) had become less effective.It was noted that when the patient was in the army it was not bad and the patient sort of hid the shaking.The patient was a wreck.The patient had not felt quite as great as he should for quite a while.The patient¿s device was replaced on the day prior to the date of this report.

Manufacturer Narrative

Concomitant medical products: product id: 7436, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# v281324, implanted: (b)(6) 2009, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 3387s-40, lot# v268107, implanted: (b)(6) 2009, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 7436, serial# (b)(4), product type: programmer, patient.(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: 4340112
• MDR Text Key: 5172329
• Report Number: 3004209178-2014-24200
• 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
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2010
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2014
• Date Device Manufactured: 05/29/2009
• 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: 00070 YR