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); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inadequate or Insufficient Training (1643)

Patient Problems Diarrhea (1811); Incontinence (1928); Therapeutic Effects, Unexpected (2099)

Event Date 12/04/2019

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 regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor patient reported that around end of september or first of october, all of sudden she noticed she was having diarrhea and accidents more than ever.She states when she first had it implanted it seems to be working fine until this happened.She states increasing and decreasing stimulation did not help.They further stated that they had an unrelated medical procedure and turned the device off and stated that ins off she seems to have no accidents since, so pt left therapy off.Patient then alleged 2 days ago it seem to turn on by itself because she could feel the vibration and had 2 accidents later.She then went back and turn ins off.Patient was redirected to their health care professional.No further complications were reported or anticipated.

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

Information was received from a consumer regarding a patient who was implanted with an implantable neuro stimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/pelvic floor patient reported that around end of september or first of october, all of sudden she noticed she was having diarrhea and accidents more than ever.She states when she first had it implanted it seems to be working fine until this happened.She states increasing and decreasing stimulation did not help.They further stated that they had an unrelated medical procedure and turned the device off and stated that ins off she seems to have no accidents since, so pt left therapy off.Patient then alleged 2 days ago it seem to turn on by itself because she could feel the vibration and had 2 accidents later.She then went back and turn ins off.Patient was redirected to their health care professional.No further complications were reported or anticipated.

• 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: 9410911
• MDR Text Key: 173573111
• Report Number: 3004209178-2019-23051
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

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: 09/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 12/04/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR