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

Model Number 3058

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Human-Device Interface Problem (2949)

Patient Problems Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Electric Shock (2554)

Event Date 07/11/2020

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 consumer via a manufacturer representative regarding a patient with an implanted neurostimulator (in s) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor therapy.It was reported that the patient was in a tractor accident and says stimulation is painful.The patient states he still feels uncomfortable stimulation in his testicles.The patient is now feeling shocking and spasms down both legs.Impedance checked done and there were 0 impedance.The manufacturer representative (rep) saw the patient in the er and turned the device off per patient's request.No further patient complications are anticipated or expected as a result of this event.

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.

Event Description

Additional information was received from a manufacturer representative.It was reported that the actions/interventions that were taken to resolve the patient experiencing painful stimulation after a tractor accident were the manufacture representative had turned the device off.When asked about resolution for the painful stimulation after the tractor accident the manufacture representative said that the patient said that the pain was still there after stimulation was turned off.The patient told the er physician they wanted the implant taken out and replaced.Upon leaving the er, the plan moving forward had not been established.The actions taken to resolve the uncomfortable stimulation in testicles were the manufacture representative turned stimulation off.When asked about resolution of the uncomfortable stimulation in the testicles the manufacture representative said that the pain was still in the groin after the implant was turned off.The patient notified their physician of this.When asked about actions taken to resolve the shocking and spasms down both legs the manufacture representative said that they turned the implant off.For resolution of the shocking and sp asms down both legs the manufacture representative said that the implant was turned off and the patient notified the physician that they were still in pain.There were no actions/interventions to resolve the 0 impedances.When asked about resolution of the 0 impedances the manufacture representative said there were no impedances.The manufacture representative said the patients implanting healthcare professional was in another state and they were unaware of any further appointments.

• 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: 10271269
• MDR Text Key: 198742241
• Report Number: 3004209178-2020-12141
• 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: 07/29/2020

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: 05/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR