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

Model Number	3889-33
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a consumer (con) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that the patient had their lead replaced on the day of the report.It was noted that the issue was resolved at the time of the report.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information was received from a con.It was reported that the patient's leads became dislodged, resulting in pain that felt like electrocution.That is what led to the replacement surgery.They stated that the reason for the lead dislodgement was unknown.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 6513704
• Report Number: 2649622-2017-04877
• Device Sequence Number: 616483
• Product Code: EZW
• UDI-Device Identifier: 00613994752437
• UDI-Public: 00613994752437
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2017

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: 01/25/2020
• Device Model Number: 3889-33
• Device Catalogue Number: 3889-33
• Device Lot Number: VA13LFF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2017
• Supplement Date Received by Manufacturer: Not provided; 05/18/2017
• Initial Report FDA Received Date: 04/22/2017
• Supplement Report FDA Received Date: 06/06/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR