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 Staphylococcus Aureus (2058); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 08/15/2019

Event Type  Injury  

Manufacturer Narrative

Phone number: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a manufacture representative (rep) via a healthcare provider (hcp) regarding an implantable neurostimulator (ins) for bowel dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Rep said the patient is three weeks post-operative and the incision site has not fully closes; it was weeping.The hcp told the patient's mother to take the patient to the pediatrician where they were tested (b)(6) for (b)(6) at the pocket site so they began antibiotics.The patient is scheduled with the hcp on (b)(6) 2019 to determine if the infection has cleared or if the system needs to be removed.The environmental/external/patient factors that may have led or contributed to the issue and the diagnostics/troubleshooting performed are not known.No device issue was reported and no further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative (rep).The hcp saw the patient on (b)(6) 2019, determined the infection was not cleared, and scheduled them for explant; the ins was explanted on (b)(6) 2019.The ins is being held at the hospital and will be picked up for immediate return to the manufacturing company.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative (rep) who noted the ins was discarded.No further patient complications have been reported as a result of this event.

• 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: 8931850
• MDR Text Key: 155624300
• Report Number: 3004209178-2019-16363
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2019

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: 11/28/2020
• 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: 08/15/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/30/2019; 09/04/2019
• Supplement Dates FDA Received: 09/03/2019; 09/05/2019
• Date Device Manufactured: 06/03/2019
• 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: 10 YR