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

Model Number 97712

Device Problems Intermittent Continuity (1121); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient for about a week at least every setting they go to they get stimulation in their legs, but not their back.The patient sat in different positions, but it didn't help.The patient stated that this issue started in early june.The patient stated that 3 days ago when the device is on and they squat over the right their stimulation will go off and give them a blast of shock so they have turned the device off for the last day and a half.The patient also stated that this happened 3-4 months ago and they talked to a manufacturer's representative (rep) at that time and they said to go to the er and they did m and then they went to see the rep sometime in may and got new settings.The problems went away until now.N additional information was received from a patient.It was reported that device stopped working.Patient reported that he has been having a lot of problems with his stimulator.Patient stated about 5 days ago from this report patient noticed ins would turn on/ off if patient leaned back or the wrong way when icing back.Patient sated when ins turns on/ off sporadic, it scares patient a little.Patient stated ins was 3/4 full , so he charged ins.Patient reported ins took a charge then it quit working all together and when it is working all it's doing is stimulation the patient's legs and not lower back.Patient stated he attempted to charge ins and it won't charge.Patient spoke with reps to try and arrange appointment.

• 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 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: 7664900
• MDR Text Key: 113270346
• Report Number: 3004209178-2018-15103
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2018
• Date Device Manufactured: 11/24/2017
• 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 Age: 60 YR