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

Model Number 37714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Pain (1994); Seizures (2063)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator.It was reported that the patient had a seizure and was in the hospital; the patient was trying to adjust the stimulation, their patient programmer said the implant was off, but the patient still felt stimulation.The caller wanted a manufacturer's representative to come out and verify that the implant was off.Additional information received.It was reported that they believed the seizures were related to the device because the night before they called the manufacturer they were trying to turn the patient's device off because the patient was feeling stimulation in both arms instead of one- the device was implanted to stimulate one arm only.During all that the patient experienced seizures.The hospital staff could not confirm this but due to the timing, and this being first time the patient had seizures, they believed the seizures were related to the device/therapy.A manufacturer's representative was able to turn the device off.Their new neurologist is in tampa area and patient has an upcoming appointment with them.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from a friend/family member of the patient reported that the patient had been feeling painful stimulation and sharp pains in their head while they were in the hospital before the ins was turned off.The ins was turned off the but patient continued having pain in their arm.The hcp determined that the seizures were not related to the ins/therapy.The decision was made to turn the ins back on and see if the patient could charge it.While trying to charge the patient's recharger belt broke.A new belt was sent to the patient.No further complications were 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: 7050551
• MDR Text Key: 92686771
• Report Number: 3004209178-2017-24198
• 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,Followup
• Report Date: 01/19/2018

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: 01/14/2016
• 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: 11/02/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 01/19/2018
• Date Device Manufactured: 02/17/2015
• 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): Hospitalization
• Patient Age: 80 YR