MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_INS_STIMULATOR

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that on friday prior to the date of this report the patient had another sudden loss of therapy.On the date of this report the clinician programmer was showing an out of regulation (oor) message during programming and a short was showing between electrodes 1-2.Impedances on (b)(6) 2014 were c/0-991, c/1-564, c/2-559, c/3-767, 0/1-933, 0/2-944, 0/3-1388, 1/2-89, 1/3-757, 2/3-743.The patient was programmed using 1-2, 2.7v, 120us and 185hz.Therapy impedance was 103 ohms, 23.7mz.The patient had gotten a shock when electrode z was conducted at 3v and was not getting the shock at 0.7v.No intervention or outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental mdr will be submitted.

Manufacturer Narrative

Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 3387-40, lot# j0340295v, implanted: (b)(6) 2003, product type: lead; product id neu_unknown_ext, serial# unknown, implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v017959, implanted: (b)(6) 2007, product type: lead; product id 748240, serial# (b)(4), implanted: (b)(6) 2007, product type: extension; product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 4387766
• MDR Text Key: 5363992
• Report Number: 3007566237-2015-00035
• 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: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

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 Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 01/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• 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: 00059 YR