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

Model Number 37714

Device Problems High impedance (1291); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Impedance Problem (2950)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Seizures (2063); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Loss of consciousness (2418)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from consumer via a manufacturing representative (rep) regarding a patient with an implantable neuro stimulator (ins).It was reported that 1.5 weeks ago patient had a seizure, did a back flip off her bed and was unconscious when authorities found her; 2 days ago from this report patient started feeling stimulation in abdomen and into lung; today, (b)(6) 2018, rep met patient in the emergency department (ed) to turn off stimulator; when stimulator is off patient no longer feels stimulation in lungs; patient stated that now that stimulator is off, the pain in her legs is excruciating; patient is in ed for evaluation; an impedance check shows electrodes #1, #3, #5 are out of range at > 10,000.The issue is not resolved at the time of this report.The rep indicated to contact the health care professional (hcp) for further information.Unknown if surgical intervention will occur, rep will follow up for more information.Additional information reported that imaging appears normal and health care professional (hcp) recommended that patient leave her stimulator off for the time being.No further patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

Event Description

Additional information: it was reported that the cause of the seizures/unconsciousness, stimulation being in the abdomen and the high impedances were not determined.The patient's ins has been turned off.This information was confirmed with the physician/account.No further information was reported.

Manufacturer Narrative

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

Event Description

Additional information received from the representative.It was reported that all of the patient's pain was below the knee in their right leg.During reprogramming the representative was only able to get paresthesia above their waist, even at the bottom of the lead.As the voltage increased, stimulation migrated into their abdomen and ribs.The patient was going to follow up with their doctor to discuss options.An impedance check showed that electrodes 1, 3 and 5 were out of range.No further complications reported.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 7252376
• MDR Text Key: 99381012
• Report Number: 3004209178-2018-02360
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2018

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: 10/28/2016
• 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: 02/06/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 02/08/2018; 04/10/2018
• Supplement Dates FDA Received: 02/28/2018; 05/02/2018
• Date Device Manufactured: 12/04/2015
• 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 Outcome(s): Other
• Patient Age: 42 YR