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 Dizziness (2194); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that starting sunday prior to the date of this report that patient felt like the device had a shot circuit but had not heard anything.It felt like buzzing intermittently in the patient¿s head and he got dizzy.Therapy had been good besides that and nothing had specifically set it off that the patient remembered.The patient had stopped taking his depression medications prior to halloween.There were no falls or traumas noted.Impedances were: 0 and 1 ¿ 50 ohms and c,0 and c,1 were normal.Impedances were first noted at the patient¿s last programming session on (b)(6) 2014 along with the 273 drain.The patient was programmed with +2-1-0, 2.0v, 60pw, 185 rate and 900 ohms.A longevity estimate calculation was done and showed 79 months or 6.58 years.Battery voltage was 3.74v.The patient had elected to have the battery changed and impedances would be checked intra-operatively, they would change the extension if it was still showing a short.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.

Event Description

Additional information received reported that the patient had their left stimulator replaced on the date of this report.This had not corrected the short circuit between electrodes 0 and 1.The surgeon had then replaced the extension and the impedances had come to a normal range.

Manufacturer Narrative

Concomitant medical products: product id 7426, serial# (b)(4), implanted: (b)(6) 2009, product type: implantable neurostimulator; product id 3389-40, lot# j0104134v, implanted: (b)(6) 2001, product type: lead; product id 7495-51, serial# (b)(4), implanted: (b)(6) 2001, product type: extension; product id 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension; product id 3387s-40, lot# v227370, implanted: (b)(6) 2009, product type: lead.(b)(4).

Event Description

Additional information received reported that surgical intervention was planned, but nothing had been scheduled.

• 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: 4291732
• MDR Text Key: 5269063
• Report Number: 3004209178-2014-22406
• 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,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2010
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2015
• Date Device Manufactured: 02/19/2009
• 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: 00051 YR