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

Model Number 7426

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Cognitive Changes (2551); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported the patient had a shocking/jolting sensation and a tingling and clicking feeling over the implantable neurostimulator (ins) while walking and sitting in a chair.The tingling started about a month prior to this report and had happened 2-3 times over the last month.The shocking sensation had occurred three times over the past few months prior to this report.The patient noticed the sensations when taking their parkinson¿s medication.The patient felt a tingling and a possible loss of therapy temporarily while the sensations occurred.The patient had felt the tingling feeling or pin in their hip and leg once.The patient has had falls, but the manufacturing representative did not associated the falls/trauma with this problem.Impedances were measured and they were within normal range.Therapy impedance was measured to be 852 ohms.The manufacturing representative stated the tingling and clicking sensation did not seem to be related to position since it happened when the patient was sitting and walking.The patient¿s system checked out normal and the patient did not have a loss of therapy.After the manufacturing representative met with the patient, the patient¿s caregiver stated they did not think the symptoms were related to the therapy.The caregiver stated the patient had some mental/psychological/cognitive issues.The patient was going to keep a diary if and when the clicking or tingling happened again.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.

Manufacturer Narrative

Concomitant medical products: product id: 3389-40, lot# j0327190v, implanted: (b)(6) 2003, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension.(b)(4).

• Brand Name: SOLETRA
• 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: 4377347
• MDR Text Key: 5287539
• Report Number: 3004209178-2015-00009
• 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: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2011
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2014
• Date Device Manufactured: 06/28/2010
• 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: 00071 YR