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

Model Number 37714

Device Problems Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)

Event Date 02/01/2018

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 consumer regarding a patient who was implanted with a neurostimulator (ins) for failed back surgery syndrome and spinal pain.Information was reported that a patient said that when she is laying down, the stimulation is so high that it's painful and hitting a "vital organ".The patient said it's hitting her female organs on her right side, but she doesn't have an ovary on that side anymore so it's probably hitting her appendix and intestines.The patient said she can't go to the bathroom and has a hard time peeing.The patient said she'll be laying down, but her patient programmer (pp) shows she is upright so she knows it's not working right.The patient said the voltage will change but she can't get it to do down.The patient then said when she tries to get it to go down, the pp blinks and shows the battery and "something weird" and then the screen will shut off.The patient could not describe what "something weird" was so it could not be determined what she was seeing, but the patient said she can't adjust stimulation.The patient said the voltage will stay the same but the pp screen will shut off.The patient has changed the batteries in the pp multiple times and that has not resolved any of the issues.The patient also wanted to turn stimulation off completely because even with adaptive stimulation off, she felt it was still hitting a "vital organ".The patient was assisted with turning adaptive stimulation and then the whole ins off.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

Concomitant products: product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the patient programmer (pp) batteries were depleting quickly.The patient she met with her health care professional (hcp) and manufacturer representative (rep) on (b)(6) 2018.It was stated that she put in new batteries that morning and at the appointment they had to change the batteries again.The patient stated the pp worked during the appointment but when she got home and she laid down, her stimulation "jumped up"/increased.It was stated that she went to turn the stimulation down but the pp wouldn't connect so she changed the batteries again and she connected.The patient stated the stimulation changes on its own, she would see the numbers go up and down.The patient stated she has turned off her ins using her insr and was scared to use her pp again.The patient stated she had not been feeling well and was highly medicated because of the pain of her organs being zapped/electrocuted.It was confirmed that the programmer was blinking and changing stimulation by itself.The patient was transferred to repair and the device was replaced.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer.It was reported that the cause of the patient's issues was not determined.They couldn't shut the unit off and the issue had not been resolved.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from legal representative of the patient claiming that device was implanted in 2014 for back pain.Patient had been doing fine until february (b)(6) 2018, when they claimed they were shocked by the device on 9 separate occasions.The first alleged "shocked" occurred at a party.A subsequent "shock" happened again while patient was driving home.Patient claimed that they pulled their vehicle over and woke up later laying on the side of the road.Patient claimed they could not feel when they had to use bathroom that they lost control of the bladder and was in pain.Device was still implanted.No further complications were reported as a result of this event.

• 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: 7285884
• MDR Text Key: 100567302
• Report Number: 3004209178-2018-03687
• 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: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Date Device Manufactured: 06/06/2014
• 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: 55 YR
• Patient Weight: 75