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

Model Number	3889-28
Medical Device Problem Codes	Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
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 healthcare professional via a manufacturer¿s representative (rep) regarding a patient with an implanted neurostimulator (ins) for gastrointestinal /pelvic floor therapy.It was reported that the lead would not pull out with pull pressure from the percutaneous extension.Upon inspection, it appeared the zero electrode was bent which could have explained difficulty in removing lead from extension per the physician.It was stated maybe the lead was pushed too far in when stage 1 (trial) was done.The issue was resolved and the lead remained implanted.No symptoms were reported, patient was alive with no injury and no further complications were reported or are anticipated.

• 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: 6769134
• Report Number: 2649622-2017-07671
• Device Sequence Number: 1490997
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1GN7Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/04/2017
• 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