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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427V-NP
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Bruise/Contusion (1754); Incontinence (1928); Pain (1994); Complaint, Ill-Defined (2331); Electric Shock (2554)
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, healthcare provider (hcp), and manufacturer representative (rep) regarding the patient's implantable neurostimulator (ins) for bladder pain. Information was reported that the patient has been having problems with falling. He is not sure if the falls are related to his ins or not, and it not able to undergo an mri due to the risks involved. The patient intends to have their system removed. The patient doesn't like their system, it hasn't worked for them in terms of bladder control. Note that this spinal cord stimulator (scs) was implanted off label for bladder pain. Additional information was reported that it was not determined why the patient's device was not working that day for their bladder control when it was examined at their doctor's office. The patient's device was tested and they determined it was working, however upon the patient getting home their side of their abdomen was hurting. When the patient lifted up their shirt the patient's entire side had a massive and painful bruise. Their bladder controller issue has not been resolved. The patient has turned off their device off since about a month ago after they saw the bruise. The patient also noted continued to get shocked from their tv and radio whenever she turns them on. The patient is currently in need of a brain mri, but the patient cannot get the scan because the leads they have are not mri compatible. The patient has seen several doctors to get it removed and replaced with a mri compatible device and leads, but "were not available. " the patient noted that the device has caused them substantial harm. Until the patient had their device checked they had never experienced bruising, pain, or shocks. The patient has turned their device off full time now. No further information was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was reported that the patient's medical history includes they do not have a bladder anymore, and their current ins was placed for pelvic pain only, and not a urologic disorder. No further information was reported.
 
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Brand NameSYNERGY VERSITREL
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9444700
MDR Text Key175272868
Report Number3004209178-2019-23479
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2010
Device Model Number7427V-NP
Device Catalogue Number7427V-NP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/28/2009
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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