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

Model Number 3058

Device Problems Self-Activation or Keying (1557); Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)

Patient Problems Fall (1848); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Insufficient Information (4580)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had seen a power on reset (por), it was reviewed that this meant the device had turned off and reset to shipping parameters.The patient reported they started seeing the por code the day prior to the report and that it was not doing what they expected it to do with their bladder retention and reported this loss of therapy had been present since implant.They reported they had tried all the programs and talked to their doctor about it and they were going to possibly change the programming because they had tried all 4 settings and turned the numbers up and down and it was not working like they expected it to.The patient reported they tripped and fell onto their knee on friday, but they just fell on their knee and got up again.Patient was sent physician listings and redirected to their healthcare provider to discuss no therapy results.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va1v73f serial# implanted: (b)(6) 2019 explanted: (b)(6) 2021 product type lead 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 patient had lead revision done this past wednesday.Caller reports physician do not like to change out ins if there is no need.Caller reports patient had lead revision done due to not working well, unknown when that started.Caller reports when he interrogated with 8840, longevity of the 3058 display 69.1 months remaining but had an asterisk indicating for a new neurostimulator.Caller reports patient was given a th90 handset.Caller reports the handset display 103.7 months remaining.Reviewed the asterisk longevity is inaccurate due to por that occurred in the past.Caller do not have any old record of previous settings and longevity.Caller reports patient might have seen a random physician in the past that performed a procedure that might involved electrocautery, unknown when, who or what was done, that might resulted in por.Caller reports patient is doing well.Caller reports he do not have any parameter setting.Rough longevity estimate performed: 3v/60pw/14hz.Two contacts: eri: 5.19 years and eos: 7.21 years.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the patient was not aware of what caused the device not to work as well as they thought it would.There had not been an opportunity to interrogate the system or have the patient try different programs.The rep only saw them for the lead revision, which was successful.The original lead was not kept and the patient kept the original battery active in their body.It was noted patient weight was unknown.

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 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: 7742719
• MDR Text Key: 116724677
• Report Number: 3004209178-2018-17167
• Device Sequence Number: 0
• Product Code: EZW
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2021
• 2 Devices were Involved in the Event: 1 2

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: 01/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/02/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/06/2021; 10/19/2021
• Supplement Dates FDA Received: 10/03/2018; 10/11/2021; 11/17/2021
• Date Device Manufactured: 07/31/2017
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female