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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 3058
Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Tingling (2171); Discomfort (2330); Electric Shock (2554)
Event Date 07/19/2020
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 a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that yesterday they were swimming and felt a little extra tingling.They said that the sensation was stronger stimulation and was a tiny bit uncomfortable where they normally feel stimulation.After swimming they said the sensation lasted for a couple of hours, so they turned stimulation down and that resolved the stimulation sensation issue.The patient had not yet increased back to the original setting.The patient had a follow up appointment 2 weeks after implant and the healthcare professional said everything looked good and they were good to go.Patient services reviewed information and told patient to monitor symptoms and if it occurs again to contact their healthcare professional.
 
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
Additional information received from the patient stated that increase speed of swimming was the circumstances that led to stimulation too strong.The patient got out of the pool and turned it way down.It took a day for it to be resolved.The patient actually switched programs and could not get things right for a few weeks.It was way less effective than the external was and it took a lot longer to feel better than they thought it would.The patient to back to program 1 at 3.8 which is higher than they had it with the external, but it works and patient only get mild uncomfortable jabs with positional changed but still totally worthy.
 
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Brand Name
INTERSTIM II
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key10307405
MDR Text Key199846931
Report Number3004209178-2020-12600
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00613994913654
UDI-Public00613994913654
Combination Product (y/n)N
PMA/PMN Number
P970004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 09/11/2020
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 Date08/14/2021
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/20/2020
Initial Date FDA Received07/22/2020
Supplement Dates Manufacturer Received09/08/2020
Supplement Dates FDA Received09/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age35 YR
Patient Weight62
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