MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B31030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Confusion/ Disorientation (2553); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
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
It was reported that the tunneller broke in half in side the patient while pulling the extensions out of the tunnel.Incision done to remove the broken part of the tunneller inside the patient, extensions pulled out manually.
Additional Manufacturer Narrative
H3.Analysis of the tunneling tool (lot# hg8wpl4) found the tool was broken at the threaded end.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.
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
It was reported that the cause of the issue was not determined.Extensions were pulled out without the tunneller, and the broken part of the tunneller was removed with an incision.The tunellizer broke in two at the time of removal, more precisely during the passage of the extensions in the retroauricular path to the subclavicular region.This rupture required significant traction on the extensions to retrieve them, as well as an additional cervical incision to extract the metal fragment that remained trapped under the skin.The standard procedure is to perform tunneling from the retroauricular incision (above the ear) to the subclavicular compartment to receive the pacemaker.The surgeon first performs this journey with a thin tip adapted to the tunellizer, in particular because of the presence of a voluminous external jugular vein in this patient.Once the tunnel has been created, the initial tip is replaced by the one used to attach the two extensions, then the tunerizer is removed in the opposite direction, bringing the extensions back to the retroauricular incision.However, during this withdrawal phase, strong resistance was encountered at the cervical level, leading to the failure of the tunellizer halfway through.A cervical counter-incision was then made to allow the extraction of the metal fragment and the release of the extensions.An unplanned incision had to be made, which led to increased risks related to healing, a potential risk of infection and a possible increase in post-operative pain.This event also created additional stress for the surgeon.(b)(6) 2025, the patient presents with a state of confusion requiring treatment with clozapine, with no additional pain compared to his pre-existing condition.On (b)(6) 2025, the patient is wide awake, calm, and comfortably installed in his chair.He responds correctly to simple and complex commands, without presenting a sensory-motor deficit.However, it manifests a temporo-spatial disorientation, indicating temporal confusion (1956 and then 2026 before 2025), as well as a global psycho-motor slowdown.He knows he's in the hospital for his parkinson's disease but doesn't mention surgery.The resting tremor of both upper limbs is mild and not blocked.1 actions taken in the healthcare establishment for the care of the patient: removal of the medical device and making of an additional incision.

• Brand Name: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22806981
• Report Number: 2182207-2025-02082
• Device Sequence Number: 15691185
• Product Code: MHY
• UDI-Device Identifier: 00763000426361
• UDI-Public: (01)00763000426361(17)270626(10)HG8WPL4
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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: B31030
• Device Catalogue Number: B31030
• Device Lot Number: HG8WPL4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 08/17/2025; 10/21/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 08/19/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2025
• 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 Sex: Unknown