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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
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 lot# serial# (b)(4) implanted: (b)(6) 2015 explanted: product type implantable neurostim ulator. 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 they charge it too long. Pt had not charged 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 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.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, 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 Key12068655
MDR Text Key258691347
Report Number3004209178-2021-09995
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2017
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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