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

Model Number 3058

Device Problems Unable to Obtain Readings (1516); Impedance Problem (2950)

Patient Problem Pain (1994)

Event Date 12/21/2020

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 friend/family member via a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the rep met with the patient the day of the report for reprogramming, the patient's mom told them the patient was having pain at the pocket site.The rep interrogated the ipg/lead and found an impedance at electrode 0 at 1.0 volts.All others were not out of range.They went through programs that did not utilize 0 electrode to confirm there was no pain with stimulation.The patient did not experience any pain.Stimulation was left on electrode 3- and electrode 1+, and stimulation was felt on their left buttock at 1.2 volts.The patient's mother was instructed to increase only if the patient was not experiencing 50% improvement.If any questions or if pain came back, they were advised to call the office.The patient's mother was not aware of any environmental or external patient factors that may have led to or contributed to the issue.An impedance test was conducted along with program exploration.The issue was resolved at the time of the report.Additional information was received from a manufacturer representative (rep).The rep reported that the impedance at electrode 0 was a question mark.All the others were good.The patient was not having issues with the therapy, and the cause of the impedance was unknown.They did not increase the voltage in an effort to clear the impedance for fear of causing the patient pain.They felt stimulation at 1.0 volts and left the office with comfortable stimulation in the appropriate area without pocket pain.

Event Description

Additional information was received from a healthcare provider via a manufacturer representative (rep).The rep reported that the patient's mother had initiated an office visit due to pocket pain and being unable to adjust stimulation with the icon due to pain.When they used the clinician programmer to interrogate the system, the impedance test had shown a question mark at the electrode previously indicated.The patient felt pain when the impedance test was run.The physician and nurse practitioner were aware of the findings.As of (b)(6) 2021, the physician had scheduled the patient for exploration of the pocket and full replacement due to their complaints of continued pain.The physician replaced the system from the left to the right side.They swabbed the ipg site for culture/infection, but the rep did not know the findings.Additional information was received from a healthcare provider (hcp).The hcp reported that there was a device concern, therapy issue, or procedure/use issue when they swabbed the ipg site for culture/infection, but there was no growth.The issue was resolved at t he time of the report.

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.

• 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: 11197749
• MDR Text Key: 243861478
• Report Number: 3004209178-2021-00994
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR