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

Model Number 97810

Device Problems Failure to Deliver Energy (1211); Failure to Interrogate (1332); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Communication or Transmission Problem (2896)

Patient Problems Micturition Urgency (1871); Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Electric Shock (2554); Insufficient Information (4580)

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor and fecal incontinence.It was reported that the reason for call was patient reported they have not charged their stimulator for a couple of months and have been going to the bathroom on their own, but they have bladder urgency ("gotta run to go urine").Patient said a couple of months ago, the lady at their doctor's office told them to shut the whole thing off and they got a message on the handset that it needed to be charged up.Pt said, last night, they wanted to try to charge their implant back up but the machine was acting up, it was blinking off and on, so they just shut it off and that stopped.Asked patient if the issue had happened before last night and patient said no, it never happened to them, it kept doing that a couple months ago.Agent offered to help patient use their equipment and pt went to get it, provided the serial number for the charger.Pt said they have not charged the equipment in a couple of months, the charger has not been charged in a couple of months.Agent reviewed: they can call back for assistance once the equipment was charged.Note: pt provided confusing information. the patient called back for assistance charging their ins however patient also mentioned additional event details.Patient reported the reason they turned therapy off was because it has been acting up and patient was feeling stimulation sensation in their back and it was like sticking and shocking them.They had it off for a while per the instruction of their physician.Patient indicated their physician told them they will always need the interstim implant unless they want to get a "bag" for their bowel issues.Reviewed how to start ins charging session and patient was able to do so successfully with ins battery at 10%.

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.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient and their husband.Patient and patient's husband called back for assistance connecting external equipment to ins.Patient stated their muscles felt tight and wanted to know what to do with stimulation.Reviewed stimulation expectations and option to decrease.Patient husband attempted to connect to ins with communicator, but kept getting no device found message.Reviewed need for ins to be charged in order to connect with communicator.Patient was able to connect to ins with recharger and saw 10% battery.Patient will charge ins and attempt to connect with communicator once ins is charged.Patient will call back if further assistance is needed.

Manufacturer Narrative

Continuation of d10: product id wr9220 lot# serial# (b)(6) product type recharger.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.Patient called back and reiterated the pain "down there" that they had been ex periencing and how the ins had been turned off for awhile.They mentioned how they'd been having episodes of frequent urination and that they had charged the ins all the way up but it only got it to 80% charge and it was supposed to go to 100%.Patient stated they had a "nasty fall" last week to the side where their stimulator was and now they couldn't "make #2," that they were constipated and bloated, and that had never happened before for them.Patient stated they were told to "turn it off," but the patient stated they didn't want to "turn it off" and that they were uncomfortable, and they had been moving around this morning and walking to "see if this could calm down" and that they took "a little bitty pill, lacatid," but that hadn't helped.Patient stated they were drinking water but nothing was coming out #2 wise all week and all they were doing was urinating.Patient was unable to clarify who told them to turn their therapy off post-fall and then said maybe their managing health care provider (hcp)? patient stated their managing health care provider (hcp) had bumped the stimulation up a little and they were fine, but they were 'hurting down there."it was unclear when the hcp had "bumped the stimulation up." patient services redirected the patient to follow up with their health care provider (hcp) to check their implanted system since the fall and to discuss their therapy concerns, but offered to assist the patient in trying to decrease the stimulation to see if that helped with their issues of constipation, bloating, and pain; however, the external devices were dead.Patient was going to charge the external devices and call back for assistance in connecting to their settings and decreasing the stimulation.Patient stated they understood they also needed to reach out to their hcp to check the implanted system and discuss their therapy concerns.Please note that patient information is very difficult to follow, and patient services did their best to document the reported information.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 18655605
• MDR Text Key: 334781826
• Report Number: 3004209178-2024-03816
• Device Sequence Number: 1
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: 07/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2024
• Date Device Manufactured: 02/10/2021
• 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 H11...."; "SEE H11...."; SEE H10...
• Patient Sex: Female