MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem Discomfort (2330)

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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The patient reported that he thought somehow, he changed his stimulation because now when he laid down he felt stimulation when it used to be off.The patient reported that he let his ins go dead because he didn¿t like the stimulation sensation when laying down.The patient reported that a manufacturer¿s representative (rep) changed settings a few years ago but he didn¿t like the setting.The patient communicated with the patient programmer (pp) to the ins and it showed that stimulation was on.It was confirmed that the therapy was on and adaptive stimulation was enabled.It was confirmed that the group selected had adaptive stimulation enabled.It was confirmed that the pp was displaying the correct position and amplitude.The patient reported that on group a laying flat position was at 2.25v.The patient was assisted in decreasing stimulation to 0.0v but stated he still felt stimulation.The patient was then assisted to change stimulation to group b.The patient decreased stimulation from 2.85v to 0.0v and stated he could feel stimulation decrease.The patient reported that when he decreased to 0.0v laying down in group b, he experienced the lower limit screen.The patient then stood up and laid back to see if the setting stuck, but stated he felt an uncomfortable level of stimulation and when the pp was checked, stimulation was at 2.20v and that patient stated ¿it feels like it¿s at 600.¿ the patient was assisted again in decreasing stimulation to 0.0v but stated he could still feel stimulation.The patient was assisted in turning stimulation off and the patient confirmed that stimulation stopped.The patient was redirected to their healthcare provider (hcp) to check the status of the ins.No further complications were reported.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7560987
• MDR Text Key: 109890374
• Report Number: 3004209178-2018-12368
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

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 Expiration Date: 02/14/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/01/2018
• Date Device Manufactured: 03/19/2013
• 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