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

Model Number	3889-28
Medical Device Problem Codes	Unsealed Device Packaging (1444); Device Damaged Prior to Receipt by User (1570); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a patient who was being implanted with a neurostimulator.It was reported that the sterile packaging of the lead looked compromised.Although it was not opened, it appeared there was slight water damage on the tyvek component of the packaging.The healthcare professional (hcp) made the decision to use the lead and, once it was deployed in the patient, they tested the electrodes looking for patient sensory and motor response.The 3 and 2 electrodes seemed to work and produced the appropriate responses, but the 1 and 0 electrodes did not garner a response from the patient.A decision was made to open a new lead and the problem was resolved.There were no symptoms or further complications reported or anticipated.
Additional Manufacturer Narrative
Analysis of product id# 3889-28 found no anomaly as the returned device passed all functional testing in the laboratory.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Continuation of medical product: product id: neu_stylet_acc, serial# unknown, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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: 6965744
• Report Number: 2649622-2017-12801
• Device Sequence Number: 566517
• Product Code: EZW
• UDI-Device Identifier: 00643169887923
• UDI-Public: 00643169887923
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 12/14/2017

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: 09/15/2021
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1KSM2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 10/18/2017; 12/01/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 11/03/2017; 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR