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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 Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Burning Sensation (2146); Electric Shock (2554)
Event Date 08/01/2021
Event Type  malfunction  
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins). It was reported that they have had some bad falls right on the implant site, but could not recall when they happened, but that they might be related to the issues they are having. Pt noted that a couple of months ago, they have felt electrical sensations that have gotten worse at times. Pt said one time they were walking in (b)(6), and they were aware that they had not turned on their stimulator, and out of no where, they felt like an electrical burning from the bottom of their bra area to the bottom of their feet, almost like something outside of them hit, and they felt more and more electrical sensations in their legs. Pt said it feels like they have their stimulator set way up high but they don't. Pt also noted that their setting for when they lay on their side only works on to lay on one side but not the other. Pt said the issue is becoming aggravating. Pt said they lost the name for their medtronic rep. The patient was redirected to their healthcare provider to further address the issue.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12715426
MDR Text Key284314321
Report Number3004209178-2021-16080
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 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2016
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 Received10/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/24/2015
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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