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

Model Number	3889-28
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional (hcp) and a manufacturer representative (rep).It was reported that the plastic casing of the lead came slightly undone and exposed the wire of the lead below the electrodes.The lead was tested and it still worked.It was noted that the wire was covered up when the percutaneous extension was placed.The hcp tested each electrode and the patient was still getting a motor response.The patient was being tested during an advanced evaluation and felt the appropriate stimulation vaginally.It was indicated that it was unknown if there were any environmental, external, or patient factors that may have led to the issue.The rep noted that they proceeded with the trial and indicated that the patient was stage 1.The rep reported that stage 1 was going well at the time of report and asked if the lead should be revised if the patient goes to full implant.The rep was reviewed that it would be a medical decision.It was advised that even if the compromised part is inside the header block it may be best to revise the lead as the lead would be more susceptible to issues in the future if it's already compromised.No further complications were reported or were expected.
Additional Manufacturer Narrative
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: 6486750
• Report Number: 2649622-2017-04853
• Device Sequence Number: 13789097
• Product Code: EZW
• UDI-Device Identifier: 00643169651111
• UDI-Public: 00643169651111
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 01/24/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1E6TN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR