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

Model Number NEU_INS_STIMULATOR

Device Problem Low impedance (2285)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported there was an impedance issue of unknown value on electrodes 9 and 11.It was noted the patient had their battery changed in (b)(6) and two electrodes shorted after the case.Since then the doctor couldn¿t program around the shorts and had turned the deep brain stimulator (dbs) off.The patient status at the time of report was alive with no injury and they had a less than 50% therapy relief.The dbs was off so the patient couldn¿t function.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.

Event Description

Additional information received reported the manufacturer representative had never met with the patient.The patient was told to meet up with their neurologist asap to review his options.They were unwilling to go back to surgery at the time of report.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 3389s-40, lot# v497075, implanted: (b)(6) 2010, product type: lead; product id 37085-95, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.(b)(4).

• Brand Name: UNKNOWN NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4132520
• MDR Text Key: 4924656
• Report Number: 3007566237-2014-02794
• 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,Followup
• Report Date: 09/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• 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
• Date Manufacturer Received: 10/10/2014
• 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