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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, IMPLANTED (PAIN RELIEF)

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Model Number 97714
Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Malaise (2359); Numbness (2415); Sweating (2444)
Event Date 02/01/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The consumer reported that they had profuse sweating, an upset stomach, diarrhea and no symptom control for their lower back and legs. The patient had no symptom relief because they had to keep stimulation low due to other symptoms. The indications for use were failed back surgery syndrome and spinal pain. No device issues reported. The patient reported via a company representative (rep) five months later that his device was not working and he was not feeling well. The patient has been in bed for a while and in a lot of pain. When the device was up to the strength the patient needs, it makes his middle region (stomach and below) all numb. The patient can feel the pressure. The patient can pinch himself and cannot feel anything. The device was on 24 hours a day, it does not seem to do him much good. The patient was wondering if it would take a while. The patient needs information and help with his device. The device was on low and always has it charged up, but has to charge every 2-3 days even though the device was on the lowest setting. The patient wanted to know if this was normal.
 
Manufacturer Narrative
(b)(4). Additional review indicated the following information was previously reported in mfg report # 3004209178-2016-20376 and does not pertain to this event: ¿the patient reported via a company representative (rep) five months later that his device was not working and he was not feeling well. The patient has been in bed for a while and in a lot of pain. When the device was up to the strength the patient needs, it makes his middle region (stomach and below) all numb. The patient can feel the pressure. The patient can pinch himself and cannot feel anything. The device was on 24 hours a day, it does not seem to do him much good. The patient was wondering if it would take a while. The patient needs information and help with his device. The device was on low and always has it charged up, but has to charge every 2-3 days even though the device was on the lowest setting. The patient wanted to know if this was normal. ¿ any additional information pertaining to the above event will be reported as a supplemental report to mfg report # 3004209178-2016-20376. Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report has malfunctioned. Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.
 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6003189
MDR Text Key102218707
Report Number3004209178-2016-20552
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2016
Device Model Number97714
Device Catalogue Number97714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/14/2015
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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