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

Model Number 3058

Device Problem Malposition of Device (2616)

Patient Problems Abscess (1690); Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Staphylococcus Aureus (2058); Discomfort (2330); Impaired Healing (2378); Tissue Breakdown (2681)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.[omitted information from pe 703363194 - pump split/motor stall] the healthcare provider reported the patient had an infection in their sacrum and the healthcare provider was looking at the infection and could see the stimulator through the skin, so the ins was removed.The reported the ins was removed due to an infection around the tissue surrounding the ins.The caller then stated the patient had soreness/open sore in (b)(6) 2018 and the ins was removed the following month, (b)(6) 2019.They were going to follow-up to confirm if all components were removed.Caller stated there was an mri ordered at the time of the report to look at the sacral decubitus ulcer in the sacrum that was causing the above infection.They reported they wanted to do an mri to see if the infection was in the sacrum or coccyx bone.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Follow up information received from the healthcare professional (hcp) reported that, per progress notes (visit date (b)(6) 2019) and pathology report (dated (b)(6) 2019) and pathology report (dated (b)(6) 2019), the patient had chronic pain, more so than normal.In )(b)(6) 2019 the wound became infected which the doctor stated was ¿extremely uncommon¿.After the doctor performed an incision and drainage for the abscess and the pus was then drained when the patient¿s husband mentioned the patient had a neurostimulator at that location.It was noted that the neurostimulator device was visible through the wound.The device was then removed on (b)(6).The pathology report noted that there was an infected superficial foreign body (specimen = nerve stimulator hardware).They also reported that the patient had (b)(6) in the lumbar spine.The progress notes also reported that the generator site was healed but the left sided sacral wound had open skin with a dressing over it.The doctor noted that the sacral wound had re-opened and was not healing, probably worsened when they were in the hospital in (b)(6) 2019.The doctor was looking for a reconstructive plastic surgeon for the issue.Also, with the open wound, the doctor noted that it was not appropriate to replace the neurostimulator.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: 9134551
• MDR Text Key: 166369422
• Report Number: 3004209178-2019-18627
• 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: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

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: 08/28/2019
• 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: 09/13/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 11/07/2019
• Date Device Manufactured: 03/05/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 54