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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Burning Sensation (2146); Complaint, Ill-Defined (2331); Prolapse (2475)

Event Date 04/19/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: 13-feb-2022, udi#: (b)(4), implanted: (b)(6) 2018, product type: lead.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The nurse reported that the patient¿s ¿remoted needs to be checked¿.This happened yesterday ((b)(6) 2019).No troubleshooting could be performed due to lack of access to the product.The nurse stated that they did not know much about the controller and was unable to provide any more information regarding the issue.They did note that the patient was an inmate at a jail.Additional information received from the nurse and patient on the same day.The patient stated that they did not know what was wrong with their device and could not navigate on the programmer for some reason.The programmer showed they were on program 2 and the lightning bolt was not seen.The patient pressed the on button and saw the lightning bolt.They noted that they had tried all of the programs and only felt the stimulation on one setting.The patient mentioned that none of the programs were working but program 1 and program 2.They also stated that only program 3 and 4 worked for them.When asked if they wanted to switch to program 3 or 4, they stated that they are ¿not working because they/jail messed up the leads when they roughed her up a little bit¿.They noted that the ins was sticking out of their skin a lot more, was burning ¿like hell¿, and had shifted underneath the skin under their butt.The patient further reported that they felt the ¿leads up in her spine¿ and it was hurting really bad.When they tried to adjust it, it constricts their vagina where they ¿cannot even relieve her bladder at all¿.They could feel the muscles contracting so bad.The patient mentioned that it was burning really bad and constricting their vagina and bladder.They also reported that they had an ¿internal vaginal fistula and she now has bowels coming out of vagina¿.Also, it got their vagina so contracted they could not stand it.When asked if they wanted to turn it down, the patient stated they did not know and it was burning under their skin.The patient was assisted with using the programmer and changed to program 3 at 1.5 volts.They felt no stimulation so they increased to 5.2 volts and felt no stimulation but noted it ¿burns in her skin¿.When the patient turned the device off, the burning did not go away.It was reported that the remote (programmer) appeared to be working as intended.The patient was then taken to their cell and the nurse at the jail stated that the patient¿s device was working ok this morning and nothing had happened to them since.The nurse did note that the patient was combative with the staff the other day.The nurse reported that they knew the device was working yesterday and this morning.They also did not believe the ins had shifted.The nurse was going to make arrangements to have the patient seen at the local hospital.There were no further complications 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: 8607393
• MDR Text Key: 144950327
• Report Number: 3004209178-2019-09554
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/14/2019

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: 10/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/14/2019
• Date Device Manufactured: 04/16/2018
• 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): Other
• Patient Age: 35 YR