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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431)

Patient Problems Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Dysuria (2684)

Event Date 06/02/2020

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 patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.Patient stated she had a return of symptoms on the date she last called ps (service call - patient did not report any symptoms).Patient stated when she got home from implant surgery she felt stimulation was too high (1.3) so she decreased it to 0.7,0.8 or 0.9 and that was better).She stated she tried increasing stimulation because of the return of symptoms and gets a bladder spasm where it hurts to go to the bathroom and after going to the bathroom.Patient felt like there is a jumpo tampon inside of her and felt pressure.Patient stated her doctor did not say she had to stay on her current program.On the call she changed from p2 to p3 and increased stimulation to 3.0 she did not feel stimulation, but will remain at this amplitude and monitor symptoms.There were no further patient complications are anticipated or expected as a result of this event.Information was received from a consumer via a manufacturer representative regarding a patient who was implanted with a neurostimula tor (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.The patient reported that she was in so much pain.During a call with patient services the patient reported the same issues as before.They stated that after disconnecting from the last call they still had pain.They decreased to 2.4 on p3 and panicked, because they felt it was too strong.They went back to program 2, but still had shooting pains that felt like a uti.During the call, the patient changed to program 4 and increased to 1.5.They felt comfortable fluttering described as a heartbeat.The patient was going to continue to monitor and was redirected to her healthcare provider as needed.Patient services sent a video tutorial on how to work the handset and communicator.No further complications were reported at this time.Additional information was received from a consumer.It was reported that they were having issues with urinary frequency, retention, and pain/throbbing in the vagina which feels swelled up after increasing amplitude and also because of their urinary issues.They said they have pain from not being able to urinate, during urination, and after urination.They are still urinating 10-15 times a night.Patient services reviewed importance of not increasing amplitude higher than what is comfortable.Patient services recommended the patient continue to monitor symptoms and option to change programs again if needed.Patient services reviewed how to change programs and redirected the patient to follow up with their healthcare professional.

Manufacturer Narrative

H6 codes have been updated to reflect new information.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 a consumer.It was reported that the received a follow up letter.The confirmed that the retention symptoms were pre-existing.The actions taken to resolve were several tests at the healthcare professional¿s office but did not remember what they were called.The patient said the issues were not resolved.They have decreased the setting and turned stimulation off for a while and then turned stimulation back on.The patient was not getting rest.The patient thought that the implant would help with bladder spasms and burning.Patient services reviewed indications and reviewed general programming guidance.The patient was going to their managing healthcare professional on friday.Mdr decision updated to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.

• 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 Key: 10299061
• MDR Text Key: 199667760
• Report Number: 3004209178-2020-12481
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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 Date: 04/14/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 83