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

Model Number NEU_INS_STIMULATOR

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported that the stimulation could not be adjusted.The display showed a ¿call your doctor¿ icon and a power on reset (por) condition.The por occurred over the weekend prior to the report and the patient thought his cell phone tower was the cause of it.The accompanying error code was not known and the final cause was not determined.The patient had a loss of therapy and went to his neurology office on (b)(6)-2014; the system was reset with a physician programmer.The patient was doing well and receiving effective therapy again.

Manufacturer Narrative

(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: 4078148
• MDR Text Key: 17164102
• Report Number: 3007566237-2014-02539
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• 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: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• 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
• Date Manufacturer Received: 08/19/2014
• 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