MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number NEU_LABEL_ACC

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that, per the mri technician, the patient control device and mri guidelines were confusing and they were not sure if it needed to go into mri mode.They confirmed the patient had a 3037 patient programmer.There were no patient symptoms or further complications reported at this time.Additional information was received from a healthcare provider (hcp).The patient involved in the event was identified.When asked if the cause of the control device/programmer being confusing was determined and what most likely caused or contributed to the issue, the initial reporter responded this was in reference to the same mri guideline issue.When they searched by model number, it was confusing which guidelines were for which device; the instructions were not real clear.When asked for specifics, they noted they had pulled schematics for two devices from the manufacturer website, where one looked like a cell phone, and one looked like a smaller device (analogue maybe).They stated it did not really specifically say what specific scans they were safe for and it contraindicated on another paragraph.When asked for the specific paragraph, they were unable to provide specifics, as they did not have the information/had thrown away the paper.When asked what steps were or would be taken to resolve the issue, they replied that when they looked up the implanted device, they needed to know it needed to be shut off.It would have been good to know without having to look t hrough pages of information.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11638043
• MDR Text Key: 247345662
• Report Number: 2182207-2021-00613
• Device Sequence Number: 1
• Product Code: EZW
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_LABEL_ACC
• Device Catalogue Number: NEU_LABEL_ACC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/08/2021
• 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 Age: 78 YR