MAUDE Adverse Event Report: MPRI SURESCAN; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number 978B128

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Insufficient Information (3190)

Patient Problems Diarrhea (1811); Incontinence (1928); Pain (1994)

Event Date 12/22/2021

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor.It was reported that the patient, a couple months ago, fell off the bed, and they had an accident last night.They stated they are concerned that the fall may have dislodged the lead or caused a problem with the device.They stated prior to last night they did not have any accidents.The patient stated they have not really been feeling stimulation and stated they don't know when they started not feeling stimulation but they confirmed despite not feeling stimulation they have been getting 50% reduction in symptoms until accident last night.The patient stated they drank too much orange juice last night and reported they had diarrhea/loose stools.They stated they "can't hold anything" and they didn't notice this until it "leaked out".Pt stated they increased stimulation due to this and reported at first it was too high that it felt painful but they confirmed they decreased stimulation to a comfortable setting.The patient will monitor symptoms now that change was made and will follow up with hcp if not seeing an improvement and to have implanted system checked.Patient services agent did not ask about the circumstances that led to the reported issue.The patient was redirected to their healthcare provider to further address the issue.The patient mentioned unrelated medical history.This included patient stated they have mental illness of bipolar disorder and depression.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13119162
• MDR Text Key: 284193140
• Report Number: 2649622-2021-25639
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203726
• UDI-Public: 00763000203726
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/30/2021

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: 10/14/2022
• Device Model Number: 978B128
• Device Catalogue Number: 978B128
• Device Lot Number: VA2BSHX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 12/30/2021
• Date Device Manufactured: 01/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female