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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Unintended Movement (3026)

Patient Problems Discomfort (2330); Weight Changes (2607)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

Occupation: non-healthcare.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implanted neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal /pelvic floor therapy.It was reported the patient¿s device was raised outside the buttocks and hurt and the new device was installed deeper.The healthcare professional (hcp) clarified that the patient had been interested in having their next device implanted deeper when replaced due to a recent weight loss; the old device had shifted and was hurting.There was no note of a device issue with 2015 device.On (b)(6) 2018 the patient clarified that they weighed about (b)(6) when the first device was implanted in 2015 and lost about (b)(6) , were at about 150# when then noticed the device was more at the surface and hurt.The weight loss happened (b)(6) 2017 and was due to complications from their lupus and not related to the device/therapy.Patient stated there were no issues known with the previous device other than hurting after the weight loss.Additional information was received from the hcp: patient was seen on (b)(6) 2018: battery life showed 19 months remaining on the battery.The patient continued to have discomfort due to their weight loss last year and elected to have the pocket revised, and battery was replaced at the time of revision.No further complications were reported or are 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

Additional information was received from a health care provider (hcp).The health care physician (hcp) reported that the reason they replaced the device was that they figured the battery was rotating so they had to revise site.There were no further complications 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: 7767521
• MDR Text Key: 116598952
• Report Number: 3004209178-2018-17774
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 10/14/2016
• 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: 07/23/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/10/2018; 08/08/2018
• Supplement Dates FDA Received: 08/16/2018; 10/03/2018
• Date Device Manufactured: 04/16/2015
• 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: 74 YR
• Patient Weight: 68