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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 INCONTINENCE
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MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 97810
Device Problem Energy Output Problem (1431)
Patient Problems Micturition Urgency (1871); Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991); Urinary Frequency (2275); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 09/22/2020
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 with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported the patient said they had to decrease stimulation because they were having a lot of spasms in the vagina and were having trouble walking.Patient got a call from their doctor and asked agent to hold; the call disconnected while agent was on hold.
 
Event Description
Additional information was received from the patient.They reported that their doctor changed the medication to tylenol 3 and patient slept better.Patient repeated information from initial call (when asked said spasms started within the first two days of implant), said that experienced spasms on p4 at 0.4 v and when decreased to 0.3 v the spasms went away.Patient also switched programs yesterday to help with bladder symptom control of frequency and urgency and said that it seems to be helping.Reviewed therapy information including healing time factors and suggested patient wait longer before making further adjustments to give body more time to heal from the surgery.Patient said that they have a follow up appointment on next thursday with their doctor.Reviewed general recharging information and importance of waiting until incision site healed prior to recharging.With instruction, patient checked current battery status.
 
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.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.
 
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.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 was received from the patient.They reported that their doctor changed the medication to tylenol 3 and patient slept better.Patient repeated information from initial call (when asked said spasms started within the first two days of implant), said that experienced spasms on p4 at 0.4 v and when decreased to 0.3 v the spasms went away.Patient also switched programs yesterday to help with bladder symptom control of frequency and urgency and said that it seems to be helping.Reviewed therapy information including healing time factors and suggested patient wait longer before making further adjustments to give body more time to heal from the surgery.Patient said that they have a follow up appointment on next thursday with their doctor.Reviewed general recharging information and importance of waiting until incision site healed prior to recharging.With instruction, patient checked current battery status.
 
Event Description
Additional information was received from the patient.They reported the spasms and trouble walking resolved after changing the settings.
 
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
INTERSTIM
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 Key10584423
MDR Text Key208506274
Report Number3004209178-2020-16663
Device Sequence Number1
Product Code EZW
UDI-Device Identifier00763000203849
UDI-Public00763000203849
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,Followup,Followup
Report Date 11/11/2020
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 Date12/14/2021
Device Model Number97810
Device Catalogue Number97810
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received09/24/2020
Supplement Dates Manufacturer Received09/25/2020
09/25/2020
11/02/2020
Supplement Dates FDA Received10/04/2020
10/04/2020
11/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
Patient Weight58
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