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

Model Number 3058

Device Problem Unexpected Therapeutic Results (1631)

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

Event Type  Injury  

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 with an implanted neurostimulator (ins) for gastrointestinal /pelvic floor therapy.It was reported the patient stated her device was turned off by the healthcare professional because it was not doing anything to help her.Additional information was received.The healthcare provider reported that the patient initially felt like they had improvement and when the permanent device was placed they could not tell the difference.The device had been checked by the manufacturer representative and several different modes were used.There was no concern that the leads had changed.The patient felt like they had sensation, but no change in bowel function.The patient was not able to create a log and did not report back well.The patient had a different device from another company for back pain and was concerned they would interfere, but they did not experience interference.Patient preferred to have it turned off and eventually turned it off.Additional information received from the patient indicated that they experienced no change in therapy, the device didn't seem do anything as far as stimulating bowels or giving notice of bowel movements.The patient indicated that they experienced fecal incontinence as a result of the device not doing anything to help them.No steps were taken to resolve the issue.The patient called again on (b)(6) 2018 and again reported a lack of therapy since implant.The caller indicated that the issue was not related to positional movement and that they had not done any adjustments themselves, but a different urologist had turned the system off.The patient indicated that they would like to have the system removed and was thus advised to follow-up with their healthcare provider (hcp).Patient status is unknown at the time of this report and no device malfunctions were reported during the call.Additional information was received from the patient.They stated they did have the complete system removed earlier this year.No patient complications were reported as a result of this event.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9329820
• MDR Text Key: 168464635
• Report Number: 3004209178-2019-21907
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2019
• Date Device Manufactured: 04/21/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 57