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

Model Number NEU_INS_STIMULATOR

Device Problems Low impedance (2285); Device Displays Incorrect Message (2591); Electrical Shorting (2926)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient had an error message on his home programmer when the right ins was interrogated.This seemed to resolve after receiving advice from the manufacturer representative.An impedance check with the clinician tablet found impedance levels of 50 ohms at multiple contact combinations including the bipolar combination that the patient had been set at.It was reported the patient was not experiencing any side effects or sudden loss of symptoms control.The hcp reported the patient's battery life did not seem to be draining unusually fast though he had very low settings.An impedance test was done with the clinician programmer (8840) and found at 3.0v only one contact combination had a low impedance and was 37 ohms.The physician had concerns with the discrepancy between the two devices.It was reported no apparent therapy issues were seen but the system check indicated a short.The surgeon was contacted for consult.It was unknown if the issue was resolved at the time of the report.Surgical invention did not occur and it was unknown if it was planned.The patient was alive without injury at the time of the report.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; minneapolis
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; minneapolis
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7764431
• MDR Text Key: 117020147
• Report Number: 3007566237-2018-02357
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• 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: 08/08/2018
• 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