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

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a health care professional via a manufacturer representative (rep).It was reported that an electrode remained in patient's body after explant, and was determined by fluoroscopy.It was further reported there was a lead insertion issue and it was uncertain whether it was a technique issue or a potential issue with the patient's scleroderma.Patient was able to place the needle in the correct location and inserted the directional guidewire and was able to get to the correct location and even had to pull it back slightly in the patient.Then, they placed the lead introducer but when they were half way through the sacrum and tried to introduce the lead, the lead would not pass all the way through.They tried moving the needle deeper but still would not advance.It was determined that the lead had curved up into the foramen and when they tried to remove the lead, the 3rd contacted stayed in the patient.The doctor tried a second time and had the same result that they could not advance the lead but were able to remove the lead with no issues and the second lead was intact.It was noted they tried both the straight and curved stylet but could not advance the lead and no leads were implanted.It was mentioned the left side was more difficult than the right, but the issue was on the right side.Damage was caused during the procedure as contact 3 pulled off during lead removal.No further complications were reported.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7877077
• Report Number: 2649622-2018-15108
• Device Sequence Number: 14007703
• Product Code: EZW
• UDI-Device Identifier: 00643169887923
• UDI-Public: 00643169887923
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1PQH9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR