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

Model Number 3058

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unexpected Therapeutic Results (1631); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Urinary Frequency (2275); Complaint, Ill-Defined (2331)

Event Date 08/05/2019

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 consumer regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that the caller feels like the ins is moving around and they can feel any of three sides depending on the position they are in and it is sticking out.The patient stated that they are not moving it themselves.It is like when they are lying in bed, they will feel it poke them and they will feel different sides.The patient stated that it have always "been loose" but it has gotten worse and almost feels like it is a coffin on its side.The patient also stated that they feel like they never really gotten relief from the implant.The patient mentioned that it may have helped a little at first, but they are not getting any relief at all.The patient already called the manufacturer representative and the physician and tried all the programs.The patient stated that it feels like it may be turning on and off as they can feel it when they adjust it and then it will go away.The caller stated that the trial worked perfectly and now nothing is working right in regards to their bladder.It was recommended that they follow up with their healthcare professional.No further patient complications are anticipated or.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a manufacturer representative.It was reported that the patient was experiencing four issues with their implant: the device was not effective at reducing their retention/frequency; the implant was too close to the skin; the ins would move in the pocket; and the ins would frequently turn off on its own.It was clarified that the patient would increase the amplitude so that their toes would curl, and then the toes would release within a few minutes; therefore, they believed that the device would turn off.The patient experienced lack of efficacy despite proper stimulation at a low amplitude and multiple program changes.Troubleshooting had included reprogramming, but ultimately the lead and ins were replaced, and the ins was sutured to the tissue inside the pocket.No further patient complications are anticipated or expected as a result of this event.

Manufacturer Narrative

H3; the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, output and telemetry testing, and functional testing.The implantable neurostimulator (ins) passed functional testing; however foreign materi al was observed in the implantable neurostimulator (ins) connector port.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.

• 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: 9676988
• MDR Text Key: 177987059
• Report Number: 3004209178-2020-02726
• 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,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR