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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 97702
Device Problems Failure to Deliver Energy (1211); Overheating of Device (1437)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Sleep Dysfunction (2517)
Event Date 08/20/2020
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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that in (b)(6) 2020, the patient started having issues with their stimulator, which was explained to mean that they could still feel stimulation down their left leg but could no longer feel stimulation down their right leg.They also reported feeling a burning sensation at the ins site, which hurts more when they are sitting.They also couldn't lay down on the ins.The patient confirmed they didn't have any falls or trauma that could have contributed to these two issues.The patient did try to turn the stimulation off and the result was that the burning sensation improved slightly, but then their leg pain came back since the therapy was off, so they turned it back on.The patient hasn't seen their doctor for about a year because they never had an issue with their therapy until this event.They were redirected to see their doctor to address the therapy and symptoms.
 
Event Description
On (b)(6) 2020, additional information was received from the patient.Patient reported they had their device checked by healthcare provider (hcp) on (b)(6) 2020.After the doctor checked the implanted devices, they were unable to determine the cause of not feeling stimulation in the right leg and burning at the ins site.Possible treatment will include a shot.The manufacturer representative (rep) reprogrammed the device.The issue was not resolved.The patient was keeping it turned off at bedtime because they can't seem to get it where they needed it so they can sleep.No further complications were reported/anticipated.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
 
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Brand Name
SURESCAN
Type of Device
STIMULATOR, 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
MDR Report Key10456702
MDR Text Key204541266
Report Number3004209178-2020-14814
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00643169109513
UDI-Public00643169109513
Combination Product (y/n)N
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/28/2016
Device Model Number97702
Device Catalogue Number97702
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/25/2020
Initial Date FDA Received08/26/2020
Supplement Dates Manufacturer Received09/11/2020
Supplement Dates FDA Received09/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age89 YR
Patient Weight92
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