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

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event and explant dates are approximate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) regarding a patient's implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.Patient said they had a portion of the system explanted and x-rays show the lead or portion of the lead remains implanted.Caller indicated the reason for removal of the device was for mri compatibility and is calling about guidelines.The caller also indicated the removal occurred a couple of days ago.The call center reviewed mri compatibility information with the hcp.Additional information was received from a health care professional via a manufacturer representative.It was reported that a portion of the lead was left behind; it broke during explant and no cause was determined.It was noted that no explant of the partial lead is scheduled or planned.No further patient complications are anticipated or expected as a result of this event.Additional information was received from a health care professional via a manufacturer representative.It was reported that the patient told their pa that they had it removed, but the patient¿s managing healthcare provider had no record of removing it.The rep guessed that they had it removed by another physician.No further patient complications are anticipated or expected as a result of this event.

• 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: 9711748
• Report Number: 2649622-2020-03412
• Device Sequence Number: 11611137
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1MQYR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR