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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Energy Output Problem (1431); Loss of Data (2903)
Patient Problem Device Overstimulation of Tissue (1991)
Event Date 08/22/2021
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 patient who was implanted with an implantable neurostimulator (ins) for spinal pain. The reason for call was that they were having problems starting last night; pt stated that they woke up this morning and "reset" their settings to change from one zone to the other (patient services (pss) understood that the pt was changing groups) when they lost their old settings and went back to "some legacy stuff". Pt stated that the ins kept giving them more current than they needed (pt confirmed that they were speaking of getting more stimulation than they desired). Pt synced the programmer to the ins and stated that they were on group d with the stimulation at 1. 35 in the upright position. Pt confirmed that the adaptivestim feature and stimulation were currently on. Pss suggested that the pt decrease the stimulation; pt stated that they decreased the stimulation to 1. 30; pt noted that they were flipping between 1. 30 and 1. 45 before. Pss reviewed with the pt how to make adjustments to stimulation/adaptivestim; pt understood. Pt then stated that what was weird was that the ins wasn't automatically setting from one level to another and that they didn't have the designation of upright/lying down/etc before; pss understood that the pt didn't have adaptivestim enabled/active before and that adaptivestim was currently on/active. Pt stated that they were trying to get back to where they were before because they were still getting overdriven by the stimulation; pss reviewed with the pt again to decrease the stimulation until the desired stimulation level was reached. Pt stated that they still weren't back to where they were before this event happened and that they were hoping that pss could tell them how to go back as they couldn't find a way to do it. Pss reviewed with the pt that pss can help walk the pt through making adjustments to the current therapy programming and that pt would need to meet with a rep for further programming needs, such as reprogramming groups/settings that were lost. Pt stated that they shouldn't be able to change the settings by accident. Pt then stated that the ins will be replaced on wednesday in surgery at 3 pm; pt did not indicate the reason for the ins replacement during the call.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
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 Key12384194
MDR Text Key268683033
Report Number3004209178-2021-13057
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 08/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/14/2014
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 Received08/23/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/14/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/30/2021 Patient Sequence Number: 1
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