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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 PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97714
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Ambulation Difficulties (2544); Cognitive Changes (2551)
Event Date 07/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient and healthcare provider (hcp) regarding the patient's implantable neurostimulator (ins) for occipital neuralgia and spinal pain. Information was reported that the patient is getting an mri due to having a lot of balances problems. They are checking to see if there was any nerve damage that could have occurred during the implant of the device. It was reported that the spinal cord stimulator (scs) mri labeling is confusing because the mri tech doesn't know if she is full-body eligible. It was reviewed that eligibility must be determined by the patient programmer (pp). The patient stated that she may have nerve damage that happened from the implant of her ins. The patient stated she has had balance problems for a few months now and it is getting worse in the past month. The caller was redirected to follow up with their healthcare provider (hcp), and the patient reported that they may have the ins taken out. The change in symptoms were considered gradual. No further complications were reported. No additional patient symptoms were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer on (b)(4) 2018 reporting that the cause of the issue was unknown. It was thought to potentially be a pinched nerve from implant. Stimulation had been turned off and an mri had been performed. The mri results were unknown at the time of the report. The patient found that they could now use the bathroom properly. They still had balance problems and brain problems reported to be thought, cognition, balance, and confusion. Stimulation was still off. Patient was reported to have started at (b)(6) and currently be at (b)(6) lbs. No further complications were reported.
 
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 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 Key8005756
MDR Text Key125021890
Report Number3004209178-2018-23916
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
Report Date 01/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/14/2017
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 Received01/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/20/2016
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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