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

Model Number	3889-28
Medical Device Problem Codes	Break (1069); Failure to Deliver Energy (1211)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins).It was reported that during the implant procedure, the patient felt nothing on the lead during testing and the lead looked like it was damaged.There were no environmental, external, or patient factors that may have led or contributed to the issue.This lead was not used and a new lead was used with the issue bring resolved.No patient symptoms were reported.The patient status was noted as ¿alive ¿ no injury¿.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
Analysis of the lead model 3889-28 lot # va1gwld showed no anomalies.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: the event should include both adverse event and product problem.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: 6658350
• Report Number: 2649622-2017-07578
• Device Sequence Number: 1967814
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/01/2017

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: 05/15/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1GWLD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 07/12/2017; 07/12/2017; 07/12/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 07/26/2017; 08/01/2017; 10/05/2017
• 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