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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON Back to Search Results
Model Number 97810
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Incontinence (1928); Pain (1994); Burning Sensation (2146); Discomfort (2330); Paresthesia (4421)
Event Date 11/04/2021
Event Type  Injury  
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.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient had experienced what was described as an android recovery error.They confirmed they had an a10e handset.Taking the handset out of the case or keeping the top right strap off of the handset was reviewed.They were redirected back to the manufacturer help line if the issue persisted.The reason for the call was that their programmer got messed up.Yesterday, (b)(6) 2021, they had felt sciatic nerve pain and changed their program from 2 to 3.They increased/adjusted stimulation to a level that felt "aggressive," and readjusted it back down.Since last night, they had felt a pressure in the muscle of their spine, and a little bit of burning in the bottom of their spine.Therapy expectations were reviewed, and the patient changed the program to program 2, and confirmed stimulation was on and they had a comfortable fluttering sensation near their rectum.They also confirmed the burning sensation in the bottom of their spine had gone away.The patient was redirected to their healthcare provider to further address the issue, and encouraged to document their symptoms.They stated that on (b)(6) 2021 they had experienced a fall.They called their healthcare provider, and were directed to turn the stimulation down.On (b)(6) 2021, additional information was received from the patient.They clarified the previously reported fall occurred on (b)(6) 2021, and that it had not affected the device in any way.When asked what steps were or would be taken to resolve the sciatic nerve pain, pressure in the muscle of their spine, and burning in the bottom of their spine, they responded they turned therapy off on (b)(6) 2021 and went to a urology clinic, where a physician assistant checked their programmer on (b)(6) 2021.It was fine.The cause of the android recovery error was not determined.They clarified the patient application was inuse when the issue occurred.When asked what steps were or would be taken to resolve the issue, they stated that on (b)(6) 2021, a physician assistant reset their therapy.On (b)(6) 2021, another physician assistant reset their therapy.It was unknown if the issue was resolved.They noted they had called their ma nufacturer representative regarding the log request, but they had not called back.The physician assistant said they would not turn it in to the doctor.The device was still in use.On (b)(6) 2022 additional information received from patient.They reported they had the interstim system removed because it was started to cause them problems.Patient experienced a burning sensation at the end of their spine that radiated out and was painful.Patient also still had bladder leaking which was not as bad and could still make it through the night.Then their bladder stopped leaking and patient started to have 4 or 5 bowel movements a day and their blood pressure went up which previously they had low blood pressure.Patient also experienced tingling throughout their body.The circumstances that led to the reported issue were unknown.No further action was taken by patient services.Reviewed disposal of external devices.
 
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Brand Name
INTERSTIM
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
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 Key15271641
MDR Text Key298380430
Report Number3004209178-2022-10676
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00763000203849
UDI-Public00763000203849
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/22/2022
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 Date07/14/2022
Device Model Number97810
Device Catalogue Number97810
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/18/2022
Initial Date FDA Received08/22/2022
Date Device Manufactured01/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient SexFemale
Patient Weight79 KG
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