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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 Display or Visual Feedback Problem (1184); Battery Problem (2885)
Patient Problem Pain (1994)
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 manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.The rep reported that they were seeing the patient prior to a revision to move the pocket that is more comfortable due to pocket pain while the patient was sitting.They said the ins may be too low and causing the pain.The caller reported that the patient was using 2.8 volts since implant and the physician programmer showed 50 months battery ok.They caller did not remember seeing any por (power on reset) message but reported they were asked to enter a serial number upon interrogation and didn¿t have one.Patient services reviewed this can affect battery longevity.
 
Event Description
Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the power on reset was unknown and that the information had not been confirmed with the health care professional (hcp) as the hcp was no longer the patient¿s hcp and the patient did not have a new hcp at that time.No further complications were reported at this time.
 
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 was received from a healthcare provider via a manufacturer representative (rep).The rep reported that they had uncovered the previously reported issue themselves when they used a clinician programmer to check the patient's battery.The cause of the device asking them to enter a serial number upon interrogation was unknown, but most likely due to the battery having returned to factory settings at some point since the time of implant.It was unknown when that may have occurred.When asked what steps were or would be taken to resolve the issue, they replied that after a discussion with the attending, they decided to replace the battery and the issue was resolved.
 
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 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 Key11057068
MDR Text Key223187807
Report Number3004209178-2020-22443
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/26/2021
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 Date03/14/2019
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/21/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received12/30/2020
01/12/2021
Supplement Dates FDA Received01/12/2021
01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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