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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 97712
Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190)
Patient Problems Undesired Nerve Stimulation (1980); Sleep Dysfunction (2517)
Event Date 06/22/2021
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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that  last night the patient started having issues feeling their stimulation to their ribs which had never happened before and it kept the patient up all night. Patient had to turn their stimulation intensity down lower than normal and when the patient went to turn their intensity down they got a signal then the stimulator shut off. Caller said they could turn their stimulator on but every time they turned their stimulator on, their stimulator turned off. The patient said that when they hit the more or less intensity they got a message that said 'press neurostimulator message'. Patient was annoyed with this issue and said their stimulator was short circuited. Patient informed their manufacturer representative (rep)  about the issue today for they felt the stimulation in their stomach and ribs and the rep redirected patient to call patient services (pss) for the time being for the rep was busy. During the call, the patient pressed the on and off button which cleared the message. Pss advised caller to clear the information screen by pressing the up or down navigator key, then to turn the neurostimulator on and try communication again. The patient then decrease intensity and it showed the intensity was at 1. 55 then was turned down to 1. 50. Patient said they had turned the stim down then off for the stim was shooting into ribs. Patient told pss that the message that they were receiving at the beginning of the call was resolved.

 
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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 Key12066415
MDR Text Key258751858
Report Number3004209178-2021-09958
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
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 HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2017
Device MODEL Number97712
Device Catalogue Number97712
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/28/2016
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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