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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 Failure to Deliver Energy (1211); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Patient Device Interaction Problem (4001)
Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)
Event Date 04/07/2021
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 (pt) regarding an implantable neurostimulator (ins). The reason for call was pt states the ins is not holding a charge, pt states she would get 4 days out of charge and now gets 2-3 days. The patient was redirected to their healthcare provider to further address the issue. Pss directed to hcp to have the ins checked. Pt reports she normally runs on group b, pt states if she is in a position and turns a little bit the stim shuts off and also pulsating when shouldnt be. Pt states she gets so vibration on the right side. Pt states she also feels like shes being electrocuted from spine out when laying down that lasts about 3 seconds. Pt states doesn't do it every time laying down just once in awhile. Pt states she is not in a certain position when this occurs. Pt states this all started the same time frame. Pss provided options such as lowering stim and possibly turning o ff. Pss directed to hcp. Pt states this occurs every 1. 5-2 weeks. Pt states she does know it happens when laying on left side. Pt reports the charge does not last either. Pss advised to try another group. Pt only has one. The issue was not resolved through trouble shooting. The patient was redirected to their healthcare provider to further address the issue.
 
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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 Key11962324
MDR Text Key267051027
Report Number3004209178-2021-09029
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 06/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2017
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 Received06/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/14/2016
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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