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

Model Number 3889-33

Device Problems Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2017

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 via a manufacturer¿s representative regarding a patient who was implanted with a neurostimulator.It was reported that the patient had the stage 1 trial the week before the report and the implant procedure occurred on the day of the report.It was reported that while implanting, the doctor noticed a ¿cloudy spot¿ on the lead about 2 centimeters from where the lead entered the implant.The caller stated the doctor asked them to look at it and they had to get very up close to see it, and noted it was the size of a pin prick.The caller stated they checked impedances and everything was ok, and the patient felt stimulation post-op.The caller also noted that the pin prick was not there the week before the report.No patient symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received and it was reported that the cause of the 'cloudy spot' on the lead was not determined.The event did not result in any impact to the patient and the patient had a successfully implant.No further complications were reported.

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba,pr MN 00766 1200
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr MN 00766 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6966069
• MDR Text Key: 90743246
• Report Number: 3007566237-2017-04499
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2017

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 Expiration Date: 08/05/2020
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA19D5N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 10/26/2017
• Date Device Manufactured: 08/05/2016
• 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: 26 YR