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

Model Number	3889-28
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2019
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 healthcare professional via a manufacturer representative regarding a patient who was implanted with a neurostimulator (ins) for gastrointestinal/pelvic floor and urinary dysfunction/sacral nerve stim.It was reported that the lead was defective and was never used on the patient.When the scrub technician opened the lead and handed it to the physician.The physician noticed that the plastic casing between the tines and the electrodes were not attached leaving raw wires exposed between the tines and electrodes.The nurse opened a new lead with the same lot number and there was no defect observed.The new lead was used for the procedure and the defective lead was placed in a biohazard bad and was given to the manufacturer representative.The patient is alive and no injury was reported at the time of this report.No further patient complications are anticipated or expected as a result of this event.
Additional Manufacturer Narrative
Analysis of the lead (lot#: va23ma7) revealed the outer insulation of the lead was separated at butt joint near the distal end of the lead.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Concomitant medical products: product id neu_stylet_acc lot# unknown serial# implanted: explanted: product type accessory product analysis #703508107: analysis information -- 2020-03-04 12:47:44 cst pli# 10.Product id# 3889-28 analysis identified that the butt joint of the outer insulation was separated at the distal end of the lead [va23ma7].Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 9495920
• Report Number: 2649622-2019-24124
• Device Sequence Number: 16644599
• Product Code: EZW
• UDI-Device Identifier: 00643169864436
• UDI-Public: 00643169864436
• 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,Followup
• Report Date (Section B): 03/09/2020

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: 10/31/2023
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA23MA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/14/2020; 03/04/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/27/2020; 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR