MAUDE Adverse Event Report: MPRI SENSIGHT; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS

Model Number	B3301542M
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that there was damage to the lead packaging.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.
Event or Problem Description
It was reported that, when opening the 1.5mm sensight lead, the integrity of the internal packing was compromised.Then another 1.5mm sensight lead was going to be opened and that internal packaging was also compromised.After getting a third lead to open, it was then in-tact and the manufacturer representative (rep) could have it opened to be implanted.The manufacturer representative (rep) clarified that the issue with the packaging was a sterile seal issue.

• Brand Name: SENSIGHT
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18247782
• Report Number: 2649622-2023-34219
• Device Sequence Number: 7191842
• Product Code: MHY
• UDI-Device Identifier: 00763000426446
• UDI-Public: 00763000426446
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2023

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: 06/16/2025
• Device Model Number: B3301542M
• Device Catalogue Number: B3301542M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/01/2023
• Date Device Manufactured: 06/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."
• Patient Sex: Male