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); Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991); Shock (2072); Tachycardia (2095); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 02/12/2018

Event Type  Injury  

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) and a manufacturer¿s representative (rep) regarding a patient with an implantable neurostimulator (ins) for complex regional pain syndrome type i and spinal pain.It was reported that the patient was in the emergency room with a jolting sensation from her abdomen, down her legs, and spasms in her legs.Stimulation was off per the external devices.The stimulation was off at the time the jolting and spasms started.The patient did not have a prior history of this issue.The hcp did know if was the patient¿s typical area of stimulation.The jolting and spasms started out of the blue and the patient wasn¿t doing anything with the system when the issue started.The patient did not have any recent changes to the therapy.A rep met with the patient in the er.When the system was checked, it showed the device was at end of service (eos).The patient¿s heart rate was at 250 beats/min per the ekg due to the spasms and overstimulation.The rep tried the emergency off button and turning stimulation off using the clinician programmer, but it did not resolve the issue.The rep started a physician mode restart (pmr) and this resolved the overstimulation.Once the overstimulation was resolved, the patient mentioned they were working with a rep to do a power on reset (por) of the system.The patient noted she was trying to charge the ins when the shocking and spasms started.It appeared the ins was in overdischarge since it reached eos prematurely.Additional information was received from a rep.It was reported the battery was in eos.The rep planned to meet the patient in the hcp office the next day.The rep stated the patient was in extreme shock, saying the device was shocking the patient.The rep walked the patient through turning it down, and the patient said it was still on.The rep met the patient at the hospital.The patient was pressing different buttons on the programmer to get the device to work.The rep performed a por on the patient about one month prior.However, the patient was hospitalized, therefore the rep was unable to clear the por.The rep met the patient at the hospital and confirmed the device was off.It was unknown if surgical intervention was going to occur.No further complications were reported.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative.It was reported that the cause of the issues was that though external device showed stimulation was off, stimulation can be activated by the patient with the patient recharger at maximum.The stimulator activated was the cause of the shocking sensation.The stimulator will not turn off until a timer was activated the timer activated with the recharger per instructions from technical services in the emergency room.Stimulation was stopped.The patient was later discharged had a follow up on (b)(4) with their healthcare provider (hcp).The overstimulation was stopped with timer.No surgical intervention was planned at this time.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the shocking sensation had stopped and the patient was discharged from the hospital.When the rep checked with the clinician programmer the night the patient was in the emergency room, the rep saw an end ofservice (eos) message.It was unknown if the healthcare provider (hcp) would elect to replace the system.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: 7272790
• MDR Text Key: 100139778
• Report Number: 3004209178-2018-03345
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2018

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: 03/28/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 02/12/2018; 02/15/2018; 02/23/2018
• Supplement Dates FDA Received: 02/15/2018; 02/23/2018; 03/01/2018
• Date Device Manufactured: 05/07/2013
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 48 YR