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

Model Number 3058

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abscess (1690); Bacterial Infection (1735); Erythema (1840); Skin Erosion (2075); Urinary Tract Infection (2120); Discomfort (2330)

Event Date 06/05/2018

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 healthcare professional (hcp) regarding a patient in a clinical study with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that the patient was prescribed antibiotics by their pcp approximately two weeks ago for a uti and the patient thought the device had moved; there was discomfort at the generator site about 3 weeks ago and their skin had eroded over the distal aspect of the generator, with some erythema but no purulence or discharge, and the area was tender.The clinical diagnosis was a gluteal abscess.It was noted that the event resulted in an unscheduled clinic or office visit and was related to the device or therapy and not related to the implant procedure.Diagnostics performed included laboratory testing which found aerobic bacteria, and an examination.Interventions taken included explanted and replacing the entire system, administering keflex 500mg tid x10 days, and wound care treatment.The outcome of the event was noted to be ongoing.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported the patient¿s history of utis prior and since implant of the implantable neurostimulator (ins) was unknown; however, it was noted that the reported uti was related to the patient¿s underlying urinary dysfunction and the cause was unknown, but it was not related to the device/therapy.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the event was resolved without sequelae as of (b)(6) 2018.No further complications were reported/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: 8086202
• MDR Text Key: 127676730
• Report Number: 3004209178-2018-25745
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2019

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: 02/14/2016
• 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: 10/29/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 01/22/2019
• Supplement Dates FDA Received: 01/15/2019; 02/07/2019
• Date Device Manufactured: 08/18/2014
• 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; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 98