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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 Intermittent Continuity (1121); Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)
Patient Problems Device Overstimulation of Tissue (1991); Discomfort (2330); Electric Shock (2554)
Event Date 11/27/2021
Event Type  malfunction  
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain. It was reported that the patient's controller was not working and they weren't able to switch to their other settings. They had more than one setting, but they couldn't switch from the one they were on to their other one. They were able to turn the controller on and off and change the intensity. The patient normally had their implant on setting "g," which was set at 140. The "a" setting was more of a pulse setting, but it had been cranking up to 190 and shocking them and was getting uncomfortable. They tried brand new batteries in the controller. A replacement controller was requested.
 
Manufacturer Narrative
Date of event: date inaccurate, only the month and year are valid. 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 Key12908059
MDR Text Key281510885
Report Number3004209178-2021-17813
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109483
UDI-Public00643169109483
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2016
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/06/2015
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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