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

Model Number 97702

Device Problems Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Energy Output Problem (1431); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Improper Device Output (2953); Insufficient Information (3190); Data Problem (3196); Patient Device Interaction Problem (4001)

Patient Problems Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 04/01/2018

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).Information was reported that the patient is having issues with their device.The patient is having issues sleeping with it and he wanted to have it removed.No further complications were reported.No additional patient symptoms were reported.Additional information was reported that the patient reported that he cannot get the vibrations in his back and right hand corner of his hip to stop.The patient said if he moved his fingers around the same area or if he moved his body a certain way the vibrating would stop.The patient said that he had turned the ins off and turned the ins down to 0.0v but he still can't get the stimulation/vibrating to stop.The patient mentioned he had tried to turn the ins off using the programmer with and without antenna but he still felt stimulation.The patient said he also tried taking the batteries out of the programmer, but that still didn't stop the vibrating.The patient also said he wanted stimulation off because it was bothering him and he couldn't sleep and said ultimately he wanted the device removed.The patient kept saying the patient programmer screen was dark, the patient said this issue was resolved once the patient was walked through enabling the programmer back light.The patient was walked through turning stimulation off.The patient said he still felt vibrating.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient reporting that a manufacturer representative (rep) came to turn their device off.The patient stated they were seeing the message ¿call hcp-574¿ code.The patient stated they started feeling vibration and that was why they checked their device and that was when they noticed the code.When asked the patient stated they had not had any medical tests, procedures or other emi exposure such as security devices, that may have led to the issue.It was reported that the patient wanted the rep to come to their nursing home again and a number was provided in which the nurse could use to page a rep.It was reported that the change in vibration was considered to be sudden.The event occurred two weeks ago in (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported "doctor available" and that they had it removed.The "call your doctor 574" code and suddenly feeling vibration has not been resolved.No patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• 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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7465037
• MDR Text Key: 106743191
• Report Number: 3007566237-2018-01255
• Device Sequence Number: 1
• Product Code: LGW
• 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: 10/04/2018

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: 08/28/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 04/26/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 07/16/2018; 08/08/2018
• Supplement Dates FDA Received: 06/04/2018; 07/23/2018; 10/04/2018
• Date Device Manufactured: 02/29/2016
• 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): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 79