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); Use of Device Problem (1670); Delayed Charge Time (2586); Charging Problem (2892); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 05/26/2023

Event Type  Injury  

Event Description

Information was received from a patient, who was implanted with an implantable neurostimulator (ins).For urinary/bowel dysfunction.It was reported, that patient said they are not sure when it started, but their mytherapy part is not going the way it's supposed to be going.They noticed, in the last couple of weeks their symptoms are getting worse.And they notice, their numbers are back to zero when they recharge a week later.Their numbers are not where they adjusted it the last time they made an adjustment.They noticed, this last night when they recharged.They noticed, just about every time.Offered to assist pt to check their settings and once pt was synched to their ins they stated, therapy was off and they turned it on and adjust it up.Pt said, they realized they have been turning therapy off accidentally when they use their equipment to adjust stimulation.Worked with pt to check their battery levels once therapy was turned back on.And pt said, their ins was 100 percent charged.Pt also reported, recharging is difficult, they have a difficult time locating the ins to get connected.They spend 2 to 3 hours trying.Pt said, when they charge their ins battery level is usually at 60-70 percent.The belt never worked for them.In fact, using the belt was more difficult than how they recharge, now leaning against it with pillows holding it in place.Pt said, they think the location on their outer hip is a bad location.They frequently loose connection without moving anything.And they are talking to their doctor about potentially moving it to a more optimal location.Reviewed some recharging information and since they were 100 percent charged today, perhaps they could call back for recharging troubleshooting at some time in the future.Additional information was received, from the patient on (b)(6) 2023.When asked, about the cause of the difficulty recharging they stated, it was not known, but that it was most likely caused by issues positioning of the recharger and external equipment.When asked, what steps would be taken to resolve the issue, they stated, that they were going to have the device replaced on (b)(6) 2023, with an implant that does not require recharging.When asked, if they were able to recharge the device, they stated, that they were able to, but that it took 3 hours.When asked, about the location of the implant, they stated, that it was almost on the side.When asked, about the belt never working, they stated, that the cause was not known, but that it was most likely, due to the location of the device.They were having the device replaced by a different hcp.

Manufacturer Narrative

Concomitant medical products: product id: fp9000l, serial#: unknown, product type: accessory.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
• 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: 18405306
• MDR Text Key: 331483289
• Report Number: 3004209178-2023-26547
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2023
• Date Device Manufactured: 12/27/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 101 KG