MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Break (1069); Intermittent Continuity (1121); Self-Activation or Keying (1557)

Patient Problems Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as follows: "worked intermittently or barely worked" = asked unknown but the patient stated about 4 years ago; "was a lead problem: right side leads broken" = (b)(6) 2017.Information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(4), ubd: (b)(6) 2017, udi#: (b)(4), implanted: (b)(6) 2013, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that, about 4 years ago, the device barely worked and ¿worked intermittently¿.In (b)(6) 2017 it was determined that there was a ¿lead problem¿ and that the right-side leads were broken.The patient stated that the system was still implanted and they had a new system put in on the left side.They wondered if they should turn the right-side system as well.There were no further complications reported or anticipated.

Manufacturer Narrative

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

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 cause of the patient¿s device intermittently working/leads broken on the right side was not determined.As an action taken to resolve the issue, a revision was done.The issue was reported as resolved.There were no further complications reported or anticipated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7727228
• MDR Text Key: 116074278
• Report Number: 3004209178-2018-16843
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

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: 07/28/2014
• 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: 07/26/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/25/2018
• Supplement Dates FDA Received: 10/02/2018; 10/03/2018
• Date Device Manufactured: 02/07/2013
• 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: 70 YR
• Patient Weight: 100