MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION CATHETER PASSER; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number	8591-38
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The manufacturer representative (rep) reported that during a surgery this tunneler (i.E., catheter passer) was passed to the surgeon.The surgeon placed their hand on the plastic handle of the tunneler and their surgical glove was cut open.It was identified that the clear plastic handle of the tunneler was chipped and a piece of plastic was protruding out, which cut the surgeon's glove.The tunneler was replaced during the procedure with another tunneler from the rep's trunk stock the clinician's office discarded the tunneler in the sharps box.The rep reported this appeared to be a manufacturer defect.The rep had inspected the sterile packaging after the incident and found the packaging to be intact without any holes.No symptoms reported.Rep confirmed this surgical procedure was a spinal cord stimulation device implant.The tunneler with the chipped handle was used to pass the wires under the skin from the lead incision to the battery pocket.The rep did not have an opportunity to take any photos of the defective tunneler or the packaging.They explained that the surgeon threw the tunneler on the floor and it was immediately placed in the sharps bin in the room by the circulating nurse.

• Brand Name: CATHETER PASSER
• Common Device Name: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20679697
• Report Number: 2182207-2024-04557
• Device Sequence Number: 7196758
• Product Code: LKK
• UDI-Device Identifier: 00763000031404
• UDI-Public: 00763000031404
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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 Model Number: 8591-38
• Device Catalogue Number: 8591-38
• Device Lot Number: 0229604996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/13/2024
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female