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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); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); High impedance (1291); Failure to Interrogate (1332); Energy Output Problem (1431); Communication or Transmission Problem (2896); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 05/17/2021
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 healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that caller reported all impedances are >4,000 ohms after activating programs and patient was unable to feel stimulation.Caller will have patient get an xray today.Manufacture rep will be able to see pt on wednesday.Issue occurred after an egd procedure on may 8th.Caller was attempting to get a hold of rep due to an issue interrogating an ins.The message stated "different device detected".This was with mytherapy app.Caller attempted patient handset and communicator, then tried the office handset and communicator w/ same message.Patient services then had caller go into clinician app and was unable to connect w/ patient's handset/communicator.Caller then used office handset and communicator which allowed interrogation, no messages.Caller indicated two programs were active, and the others needed to be re-activated.The caller activated the programs and then attempted to enter the patient app which would not allow interrogation, no response with pt handset/communicator but then indicated her handset is at 8% charged.Caller then tried office handset and communicator with same issue, no communication.Patient services discussed next steps, which today patientwill have x-ray and see rep on wednesday.Patient services will send rep and email.Issue started after turning off ins for an egd procedure on may 8th.Patient was able to turn off ins, but unable to communicate w/ ins post procedure.Since this time the patient has had return of symptoms.
 
Event Description
Additional information was received from a manufacturer representative (rep).The rep reported that they saw the patient's fully charged communicator and samsung remote, the rep had no issues using the mytherapy app and the clinician app.All programs were turned on.Patient could not feel stimulation with amplitude turned up to the maximum amount.Ran an impedance check using the clinician app all leads showed impedance of greater than 4,000.All programs were then turned off, the ins is off, patient was advised to not turn the ins back on.The patient had x-rays taken of pelvic, it does not show a lead break.The patient will discuss with the physician, a revision of existing lead wire.
 
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 Key11856009
MDR Text Key251721506
Report Number3004209178-2021-08045
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 health professional
Type of Report Initial,Followup
Report Date 06/07/2021
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 Date11/28/2021
Device Model Number3058
Device Catalogue Number3058
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/17/2021
Initial Date FDA Received05/20/2021
Supplement Dates Manufacturer Received05/21/2021
Supplement Dates FDA Received06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
Patient Weight113
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