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

Model Number	355018
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the sheath peeled back on the introducer during the procedure.There were no contributing factors reported.It was replaced with a new introducer to resolve the issue.It was reported the affected product had been discarded.No patient symptoms were reported.No further complications were reported or anticipated.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 8475117
• Report Number: 3007566237-2019-00771
• Device Sequence Number: 1628998
• Product Code: EZW
• UDI-Device Identifier: 00643169660076
• UDI-Public: 00643169660076
• 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
• Report Date (Section B): 04/02/2019

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: 07/24/2020
• Device Model Number: 355018
• Device Catalogue Number: 355018
• Device Lot Number: VN4715061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR