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

Model Number 7426

Device Problem Low impedance (2285)

Patient Problems Therapeutic Effects, Unexpected (2099); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported that there was a short.It was noted that there were low impedances, less than 50 ohms on 0<(>&<)>1 0<(>&<)>2 and 1<(>&<)>2.Action required as a result of the event was reprogramming.Impedance testing was done.The issue was not resolved and the cause of the issue was unknown.The right lead was reprogrammed to contacts not affected by the short circuit.The implantable neurostimulator (ins) was programmed with 3- <(>&<)> c+.The patient had tremor and modest tremor control with new settings.Patient was alive with no injury and had less than 50% therapy relief at the lead location.The lead impacted by the short was implanted in the right sub thalamic nucleus (stn).The patient had a new thalamic lead implanted in the right ventral intermediate nucleus (vim) to better control his tremor in the left hand on (b)(6) 2014.Surgery for the right vim was scheduled prior to onset of the short circuit in the right stn lead.Additional information received reported there were no additional interventions taken or planned.The patient was not yet programmed and would be programmed in about 3 weeks or so from (b)(6) 2014.Additional information was requested but had not been received as of the date of this report.

Manufacturer Narrative

Product id 3387s-40, lot# va0euaz, implanted: 2014 (b)(6); product type lead product id 7426, serial# (b)(4), implanted: 2010 (b)(6); product type implantable neurostimulator product id 7482a51, serial# (b)(4), implanted: 2010 (b)(6); product type extension product id 3389s-40, lot# v533019, implanted: 2010 (b)(6); product type lead product id 3389s-40, lot# v952317, implanted: 2012 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2012 (b)(6); product type extension.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va0euaz, implanted: (b)(6) 2014, product type: lead.Product id: 7426, serial# (b)(4), implanted: (b)(6) 2010, product type: implantable neurostimulator.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id: 3389s-40, lot# v533019, implanted: (b)(6) 2010, product type: lead.Product id: 3389s-40, lot# v952317, implanted: (b)(6) 2012, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.

Event Description

Additional information received reported that the patient was doing well and was receiving therapy after the first programming session.

• 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: 3653662
• MDR Text Key: 4319450
• Report Number: 3004209178-2014-03769
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2014
• Date Device Manufactured: 02/01/2011
• 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