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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Unstable (1667); Malposition of Device (2616); Inadequate Instructions for Non-Healthcare Professional (2956); Insufficient Information (3190)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 02/02/2019

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 patient regarding their implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/pelvic floor.Patient stated she needed to have a pocket revision because "her body was rejecting the ins and it was too superficial".Patient stated that it was pushed out too far and she could flip the ins in the pocket.Patient stated she believes it wasn't initially placed correctly.Patient stated that it was lower on her flank and became very painful when sitting on a harder chair or laying down.Patient stated it was a sharp pain in the battery area.The planned date of revision was (b)(6) 2019.Patient stated that during the revision her device was left on and the cautery used during the medical procedure "killed" the battery.Patient stated that she had complete control over her incontinence until march 5 after she woke up from her procedure and used her pp to check stim.Patient stated she saw the screen with the doctor's face and called the hcp's office to notify them.Patient stated that she went back in april (pt did not know exact date) and stated she was told everything would be replaced.Patient stated she does not think it was a complete replacement because she did not receive a new id or new information and the therapy was still not working.Patient stated that because she wasn't "getting taken care of properly" she came to the mayo in (b)(6) where she had a new pocket and ins that is higher on her flank and reported that she was not incontinent through the night.Patient stated that when she was first implanted she had 3 months of complete control.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: 9100787
• MDR Text Key: 159515423
• Report Number: 3004209178-2019-18109
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2019

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: 02/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/20/2019
• Date Device Manufactured: 08/31/2018
• 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): Required Intervention
• Patient Age: 36 YR