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

Model Number 3058

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Device Overstimulation of Tissue (1991); Staphylococcus Aureus (2058); Sepsis (2067); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Urinary Tract Infection (2120); Complaint, Ill-Defined (2331); Malaise (2359); Test Result (2695)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins).It was reported that the patient received a replacement antenna today.It was noted that ¿things were not working properly¿ for the patient so "they switched the pt to program 1 to 1.7v from program 3 at 1.1v".It was noted the implantable neurostimulator (ins) was implanted in their right upper buttocks.The patient also noted that last tuesday "they stopped it" and they went back to their healthcare professional (hcp) yesterday where ¿they restarted it¿ (no further clarification given).In addition, the patient stated that, today, ¿she was not feeling right¿ and was sick.The patient continued, stating that ¿i got the device and it¿s been absolutely amazing for me, but my infections have become more frequent¿.It was noted that their infection ¿my infection last time, it was so bad, i had sepsis, staph, and (b)(6), so i was 10 days receiving 2 infusions a day at the hospital, so they want me to go to the (b)(6) clinic¿.They mentioned that they "thought she was going to die".These issues were reported as starting the last week of (b)(6).Further, it was reported that their healthcare professional (hcp) did not know if the patient was ¿being overstimulated¿.This concern started a week ago today.The patient again stated they were originally on program 3 at 1.1 volts and then was moved to program 1 at 1.7 volts by the pac in (b)(6).It was noted their hpc wanted them between 1.0 and 1.1.The patient was able to use their programmer and synchronize it to the implantable neurostimulator (ins) where they saw that program 1 was checked, was at 1.7 volts, but could not see the ¿lightning bolt¿ to verify the therapy was on.Follow up information received from the healthcare professional (hcp) on may 1, 2018 reported that, regarding the ¿things were not working properly¿ and ¿they restarted it¿ was clarified that they were concerned that elevated ¿pvr¿ (post-void residual?) was due to overstimulation.As a result, they turned the device off for a week and the ¿pvr¿ became normal.The cause of the ¿things were not working properly¿/overstimulation concerns was not determined.The ¿things were not working properly¿ (having to restart) issue was resolved ¿due to new remote¿.The patient¿s infection issue was clarified that they had recurrent urinary tract infections (uti) and that the patient thought they were refluxing urine.Prior to implant of the device, the patient had no utis but it was noted they had a ureter transplant.The hcp was still evaluating the cause of the patient¿s uti.It was noted that the uti was related to the patient¿s underlying urinary dysfunction and was possibly related to the ins device/therapy ¿causing higher residual¿.As an action/intervention for the uti, the patient was given low dose, long term macrobid therapy.It was unknown if the uti issue was resolved as the patient had just begun a 6 month trial.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Follow-up with the patient's healthcare provider (hcp) determined that the patient has a history of recurrent utis, and it was unknown if the current uti was related to the patient's underlying urinary dysfunction.No additional information was available from the hcp at the time of this report.There were no further complication reported or anticipated.

• 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: 7482905
• MDR Text Key: 107218661
• Report Number: 3004209178-2018-09959
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

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: 10/28/2016
• 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: 04/24/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 06/07/2018
• Supplement Dates FDA Received: 06/15/2018
• Date Device Manufactured: 04/28/2015
• 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): Hospitalization; Other
• Patient Age: 50 YR
• Patient Weight: 54