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

Model Number 3058

Device Problems Failure to Interrogate (1332); Unintended Collision (1429); Communication or Transmission Problem (2896); Loss of Data (2903); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

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 who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that  the patient reported they think their settings on their device has been cleared because they are getting device not responding message and are not able to connect with ins to adjust therapy settings.They initially stated on call getting option to select serial number (confirmed they were seeing correct serial number for ins), but when they selected serial number they were unable to connect with their ins and continued getting device not responding.They reported they also have a spinal cord stimulator from a different manufacturer (not medtronic) and clarified following falls they had to "go in and clean up" because one of the machines had broken inside the patient.They stated they are not sure if it is their medtronic interstim device that broke or their spinal cord stimulator as they stated they "did not tell me what machine broke".They stated this occurred on (b)(6) 2021 when they had back surgery and reported since then they have not been able to connect with their interstim ins.They stated their managing hcp recently relocated to fl and has since been referred to another urologist but not seen this hcp yet but stated they will contact hcp to discuss this issue.Agent had a difficult time following the patient throughout the call and made best attempt to gather all relevant  information.Agent did not ask about the circumstances that led to the reported issue. the patient was redirected to their healthcare provider to further address the issue.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that  the patient reported they think their settings on their device has been cleared because they are getting device not responding message and are not able to connect with ins to adjust therapy settings.They initially stated on call getting option to select serial number (confirmed they were seeing correct serial number for ins), but when they selected serial number they were unable to connect with their ins and continued getting device not responding.They reported they also have a spinal cord stimulator from a different manufacturer (not medtronic) and clarified following falls they had to "go in and clean up" because one of the machines had broken inside the patient.They stated they are not sure if it is their medtronic interstim device that broke or their spinal cord stimulator as they stated they "did not tell me what machine broke".They stated this occurred on july 28, 2021 when they had back surgery and reported since then they have not been able to connect with their interstim ins.They stated their managing hcp recently relocated to fl and has since been referred to another urologist but not seen this hcp yet but stated they will contact hcp to discuss this issue.Agent had a difficult time following the patient throughout the call and made best attempt to gather all relevant  information.Agent did not ask about the circumstances that led to the reported issue. the patient was redirected to their healthcare provider to further address the issue.

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13120982
• MDR Text Key: 284991387
• Report Number: 3004209178-2021-19179
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 01/07/2022
• Date Device Manufactured: 07/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female