MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Electric Shock (2554)

Event Date 12/29/2020

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 patient with an implanted neurostimulator (ins) for gastrointestinal/pelvic floor therapy.It was reported that the original caller indicated that the implanted device is misfiring.The physician indicated that the patient is getting shocks down her leg and is in agony.The medical doctor gave the patient fentanyl to reduce the pain.Troubleshooting was unable to be performed the caller did not have access to a programming device.The caller was redirected to nas to page a manufacturer representative (rep).

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.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the patient admitted to er due to sensation and unable to drive.Caller attempted to read ins and unable to find stimulator and per patient suspected end of service (eos) was about 2 years ago, and was attempted to be interrogated at that time by the rep and confirmed eos.No falls or trauma reported recently.Patient reported feeling a shocking sensation for about the past 2 years, however, it was very random and short.Today is much stronger in sensation.Caller indicated patient doesn't really have a managing hcp any longer but will recommend previous implant/managing physician to patient.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the device wasn¿t ¿misfiring¿ as the battery itself was completely dead and not delivering any power.It was unknown what caused the shocking down the patient¿s leg but the rep reported that, potentially, the lead could have shifted and may be sitting on a nerve causing pain.The emergency room doctor said the patient may not be experiencing the pain they reported.The issue seemed to be resolved as the patient was given pain medication and the pain dissipated; the patient was no longer feeling discomfort.A removal was not scheduled.

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.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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11096427
• MDR Text Key: 224530333
• Report Number: 3004209178-2020-22790
• Device Sequence Number: 1
• Product Code: EZW
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2021

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 Date: 12/14/2012
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 12/29/2020; 01/12/2021
• Supplement Dates FDA Received: 01/05/2021; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR