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

Model Number	3889-28
Medical Device Problem Codes	Component Missing (2306); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the implantable lead (lot # va1ntr8) revealed no anomaly, functionally okay.Analysis of the stylet (serial/lot # un known) revealed a broken handle.Concomitant medical products: product id: neu_stylet_acc, lot# unknown, product type: accessory section.Product id: neu_stylet_acc, serial/lot #: unknown, ubd: unknown, udi#: unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturer¿s representative (rep) regarding a patient who was impl anted with an implantable neurostimulator (ins).It was reported that the bent tip stylet was missing the top part of the white plastic where it attaches to the lead, the plastic connector.The lead was removed from the field and a new one was opened for the procedure.The issue was resolved at the time of the report.No patient symptoms were reported.No further complications were reported.
Additional Manufacturer Narrative
Correction: additional information determined that there was no patient involved with this event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a healthcare provider via a manufacturer¿s representative (rep) indicating that there was no patient in the operating room when the issue was discovered.The rep also clarified that the bent tip stylet did not have the top portion that connected it to the lead for testing.No further complications were reported.

• 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: 7578808
• Report Number: 2649622-2018-09508
• Device Sequence Number: 10833871
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 02/02/2022
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA1NTR8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 61