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

Model Number 3058

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cellulitis (1768); Incontinence (1928); Unspecified Infection (1930); Staphylococcus Aureus (2058); Stenosis (2263); Injury (2348)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date is approximate.(b)(6).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 had urine and bowel incontinence for about a year, these symptoms were related to device/therapy.The patient needed an mri and it was not known if reason for mri was related to device/therapy.Additional information was received from the patient.The patient reported they had not contacted their managing healthcare provider as they live 3 and 1/2 hours from them.They reported they were recently in the hospital for 9 days with a major infection and they had to have surgery to clear the infection and visiting nurse (vna) to monitor the wound.They reported they had cellulitis and (b)(6).They had done a series of tests and also had a scan on 2 areas.They reported they didn't have any answers yet except for serious stenosis in their spine.No further complications were reported or are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported they were in isolation for 9 days for surgery plus a 'wound vac'.The reported that the hospitalization and surgery due to cellulitis and mrsa were not related to the device, that they had mrsa 2 years prior.They reported that this time it was very serious, the surgeon stated it looked like the mrsa had been dormant, surgery had to be done to clean it out, the patient was connected to a 'wound vac' to have the area heal from the inside out.They reported it had been 1 year and 6 months that they had no control with their urine or bowels.They were in diapers 24-7 and had no control at all.They were dealing with everything on a daily basis.They were asked to clarify the spinal stenosis, they reported they couldn¿t explain the reason behind it, it was in the spinal cord all the way up to the veins in their neck.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They were asked if the hospitalization and surgery due to infection (cellulitis and mrsa) were caused by or related to the device/therapy and they answered no, not at all.They reported it was a major, very serious infection.Surgery made a huge difference.After surgery they had a wound vac, which they had come home with and had a visiting nurse for 6 weeks following.They were also asked to clarify the spinal stenosis.They explained it was in their lowerspin, straight up the spin and excess in neck area.They had a full measure of bladder testing and they still had no answer as to why they were incontinent.They also had a cat scan and additional testing with no explanation to cover it.

• 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
• MDR Report Key: 7792635
• MDR Text Key: 117431858
• Report Number: 3004209178-2018-18477
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 09/13/2018; 01/02/2019
• Supplement Dates FDA Received: 09/26/2018; 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 84