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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient¿s device ¿doesn¿t work¿ because they did not feel the ¿tingling sensation¿ anymore.It was noted that the patient may have bumped the device in a doorway.The issues occurred a ¿year and a half¿ ago.The hcp was going to have the patient try to connect to the implant using the programmer.It was also noted the patient was to have an mri (for an issue not related to the implanted device/therapy).There were no further complications reported or anticipated.

Manufacturer Narrative

Due to indrf harmonization, any previously submitted device, method, result, and conclusions codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Follow up information received from the patient reported that they had not notified their healthcare professional (hcp) for the not feeling the tingling sensation after bumping into a doorway issue.They had ¿several crisis¿ going on in their life and they could not take the time for themselves.The patient stated that now ¿i¿m in a crisis situation¿.They reported that no steps had been taken to resolve the issue and it was not resolved.There were no further complications reported or anticipated.

Manufacturer Narrative

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

• 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: 7663635
• MDR Text Key: 113183363
• Report Number: 3004209178-2018-15017
• 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,health professional
• Reporter Occupation: Health Professional
• 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: 06/14/2016
• 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: 07/03/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/20/2018; 08/08/2018
• Supplement Dates FDA Received: 07/24/2018; 10/03/2018
• Date Device Manufactured: 12/16/2014
• 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 Weight: 79