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

Model Number 3058

Device Problems Unintended Collision (1429); No Device Output (1435); Unstable (1667); Battery Problem (2885); Output Problem (3005); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Pain (1994)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neuro stimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor patient reported that they had their ins revised on (b)(6) 2018 because it was flopping around and hurting.Power on reset message when they try to turned their ins on after the revision.Patient has an appointment to see their health care professional no further complications were noted 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.

Manufacturer Narrative

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

Event Description

Additional information reported that patient fell on the ground was the cause of the implant flopping around and por (power on reset).The patient took the remote to the doctor 's office and one of the representative reset it for the patient and the por issue was resolved.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that they were unable to turn on their device.No further complications were reported or 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: 7752621
• MDR Text Key: 116096744
• Report Number: 3004209178-2018-17457
• Device Sequence Number: 0
• Product Code: EZW
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2018

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: 06/28/2019
• 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: 08/02/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 09/24/2018; 09/24/2018; 09/24/2018
• Supplement Dates FDA Received: 08/06/2018; 10/02/2018; 10/02/2018; 10/02/2018
• Date Device Manufactured: 01/02/2018
• 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: 40 YR