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 Response, Decreased (2271); Shaking/Tremors (2515)

Event Type  malfunction  

Event Description

It was reported that it had been a while since the patient had used the programmer and that they had never reviewed how to use it.There was a loss of therapeutic effect.Symptoms had a sudden onset about 2-3 days prior to the date of this report and he was not able to write because his hands had started shaking.There was no known accident or incident related to the complaint.The patient had gone to his healthcare professional and brought the programmer with him.The internal device was checked and he was told to start using the programmer again since he had not used it in a long time.It was noted that once he had given himself a treatment the shaking stopped.Further follow-up is being conducted.If additional information is received a supplemental report will be submitted.

Manufacturer Narrative

Product id 7436, serial# (b)(4); product type programmer, patient product id 7 482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v479548, implanted: 2010 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3387s-40, lot# v591417, implanted: 2010 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 7436, serial# (b)(4), product type: programmer, patient.Product id 7 482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id 3387s-40, lot# v479548, implanted: (b)(6) 2010, product type: lead.Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id 3387s-40, lot# v591417, implanted: (b)(6) 2010, product type: lead.Product id 7436, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

Additional information received reported that the patient had been implanted bilaterally for essential tremor about 4 years prior to the date of this report.The patient had used them for a while and it had been recommended that he turn the device off at night to prolong the battery life.The patient had seemed to get very dizzy when it was turned off or turned back on again so about 3 years prior to the date of this report the patient had stopped using the device altogether to avoid the dizziness.The patient had very little tremor limitation in the meantime and had very good handwriting in particular.A couple of days prior to the date of this report his handwriting had worsened.The patient had wanted to turn the device on again but when he had gone to use the remote it had not worked.The 9-volt battery was probably dead.The patient was going to get a new battery and try again.More information was received and indicated that the patient did not have concerns with their device or therapy.

• 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: 4404816
• MDR Text Key: 5122448
• Report Number: 3004209178-2015-00462
• 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,Followup
• Report Date: 12/19/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2011
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2015
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2015
• Date Device Manufactured: 06/16/2010
• 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 Age: 00082 YR