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

Model Number 3058

Device Problems No Device Output (1435); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Complaint, Ill-Defined (2331); Numbness (2415); Prolapse (2475); No Code Available (3191); Constipation (3274)

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 urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported the patient had issues with their bowels since 2016 and states when trying to get their device settings right it would interfere with their bowels.Patient states they couldn¿t move bowels for 19 days.The patient also reported a history of breast cancer, unrelated to the device, and did not report whether there were any treatments for this that may also affect bowels.The patient also reported pelvic floor medical history: she had issues with her mesh and mentioned that her bladder had dropped, and this was all from the mesh and not from implant, patient couldn¿t recall dates.The patient reported that every time she turned on stimulation her leg went numb for the past 1.5 years.Patient had problems with bladder from the mesh.The device didn¿t help, and the patient had already attempted adjustments.Patient was advised to contact their healthcare professional.No further complications were reported or are anticipated.Additional information was received from the consumer on 2018-jun-21.It was reported by the patient that the device was not helping them.The patient stated they didn¿t know how long the device had been off for but that it was off.The patient stated they found this out 1.5 months ago.The patient stated they didn¿t know if their implant was turned off or if the battery depleted.Troubleshooting was not able to be done on the call due to the patient being legally blind, which is unrelated to the device/therapy.The patient stated their health care physician (hcp) couldn¿t turn it back on because they couldn¿t get the settings right.The patient stated they were going in to get the unit on and the hcp couldn¿t get it back on.The patient reported they were having problems with urine coming out/leakage.The patient stated having issues with bowels.The patient stated they had surgeries (that were unrelated to the device/therapy) on the bladder and they were not sure what happened.Also unrelated to the device therapy, the patient stated they had a prolapsed bladder and they put it back in place and the patient stated they were not even sure it was in place.The patient reported they were getting botox to control their bladder (unrelated to the device/therapy) and they noted they might have to start catheterizing themselves.The patient¿s reason for calling in was because they had cancer (that was unrelated to the device/therapy) and they wanted to check it with an mri again.There were no further complications reported/anticipated.

Manufacturer Narrative

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

• 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: 7697058
• MDR Text Key: 114278033
• Report Number: 3004209178-2018-16013
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

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: 01/14/2017
• 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: 06/21/2018
• Initial Date FDA Received: 07/17/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/05/2018
• Date Device Manufactured: 07/14/2015
• 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): Required Intervention
• Patient Age: 73 YR