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 Erythema (1840); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091); Complaint, Ill-Defined (2331); Impaired Healing (2378)

Event Date 03/16/2019

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 implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported by the patient that they got the device implanted and the next day when they woke up it was extremely swollen and bulging out.The patient stated that it ¿got red¿ and hurt a lot.The patient stated that it was not like the other two surgeries so they knew that something was wrong.The patient called their health care physician (hcp) office and talked to the nurse practitioner and that it was month before they did anything.The patient stated that they didn¿t do a culture but the hcp told the patient that it was a staph infection.The patient stated that they removed the whole system in (b)(6) 2019 and that they were on both oral and iv antibiotics.The patient stated that two months later after the system was removed they still couldn¿t close the wound because it was so infected.The patient chose to not get the device replaced.The hcp told them that they would have to get it on the other side and the patient stated that they would rather deal with their symptoms than go through what they went through with the infection again.The patient¿s reason for calling was to inquire what to do with their external devices and if the manufacturer company disposed of the old programmer? the patient was advised that the manufacturer company did not take them and that they should speak to their hcp or their city for how to dispose of them.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer.The patient reported that the infection was resolved at this time.In response to the inquiry of the current status of the device, the patient stated they didn¿t know and noted that the doctor who removed it had left the practice.There were no further complications reported.

• 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: 9633559
• MDR Text Key: 187590713
• Report Number: 3004209178-2020-01910
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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: 07/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 02/19/2020
• Date Device Manufactured: 01/24/2019
• 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: 41 YR
• Patient Weight: 84