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

Model Number 97714

Device Problems Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508); Delayed Charge Time (2586); Battery Problem (2885); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Alteration in Body Temperature (4568); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97714, serial#: (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was both of the patient's implants were "dead" and the pt "needs" them out of their body and the pt does not trust medtronic.Pt said they have been laying on the implants and they had more back pain then when they first had the ins implanted.The ins implants did not help the patient and the pt had harness put in their back and now have back pain where they never had pain.Pt said they will call a lawyer about this but the pt could not find a hcp and they would like an hcp that deals with the medtronic device for implant removal.Pts doctor did not believe in medtronic and they put spacers in the pts spine.The ins from 2017 was "dead" after a year and a half of being implanted because the ins did not get the pts neck and they did not use it.The ins implanted from 2015 was "dead" for 6 years.During the call the patient mentioned they were frustrated that they were not monitored by medtronic and they were lost in "the system." pt said in the past when they ordered extra chargers they were never asked about the ins or the pt (pss unable to locate cases for replaced rechargers).Pt stated that when they use to charge their implant the ins battery got hot when when they charge it too long.Pt had not charged had not charge implant in a year for it was "dead" for it took 6 hours to charge for 2 hours of stimulation.Pt use to use it for 24 hours.Pt use to have to hold the paddle over them on their back but it would get so hot they had to take it off for they thought it was going to "explode" (recharger, back, and everything got hot).Pt was overheating and getting hurt during a recharge session.Pt said it was very dangerous an assured pss that they would be contacting a lawyer.Pt said they were a mentally and physically disabled and didn't know much about the implanted procedure and they did not know they were getting wires implanted.Pt said they have a unit on each side they cant lay on cause they were so skinny and it hurt when laying on anything.Patient does not trust medtronic and the ins scared them so much and they don't trust a second battery put in their back.When pss asked for an event date the pt responded by saying the battery was not lasting long toward end and it took 2 or 3 hours to charge, got hot so it scared them and they turned the ins off.Pss asked for hcp info and pt responded that the hcp provided patient services number.Patient said that they were too disabled to use a computer.Pt mentioned they had brain trauma for they were hit in the head causing neck budge and other problems in the spine, pt was hit in the head with a hammer.Pt said that they lost 100 pounds and cant gain much back which causes pain.Patient said they were 100% disabled and they can't trust medtronic and they want the implant out of their back.During call pss agent read off different physician listings phone number to pt for the pt moved to florida and switched doctors.During call pt was escalated hindering pss agent on asking clarifying questions.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12068652
• MDR Text Key: 263577492
• Report Number: 3004209178-2021-09994
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/25/2021

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: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 06/25/2021
• Date Device Manufactured: 04/06/2015
• 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