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

Model Number 3889-28

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Pain (1994)

Event Date 06/27/2018

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 consumer via a manufacturer representative regarding a patient with a percutaneous lead.[relevant medical history: patient had interstim in the past] it was reported that the patient experienced pain in their buttocks and down their leg.The patient's stimulation was off at the time of the report because the physician cut the percutaneous extension wire and the patient had not yet proceeded to stage 2.Stage 2 was scheduled for a later date, but the lead remained implanted and was not active.Contributing factors to the reported event were unknown.The physician's assistant had administered anti-inflammatory medications, but the patient did not get relief.It was reported that the issue was unresolved at the time of the report.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative.It was reported that the physician cut the percutaneous lead externally due to postponing the stage 2 date.The decision was made by the physician and the reason for postponing was unknown.The manufacturer representative was not aware of any further actions/interventions.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7646192
• MDR Text Key: 112851782
• Report Number: 2649622-2018-10635
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00643169887923
• UDI-Public: 00643169887923
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1L8YY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2018
• Date Device Manufactured: 10/25/2017
• 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: 70 YR