MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3389S-40
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for parkinson's dual.It was reported that the lead was opened and discovered to be bending prior to use.It was then noted that the lead was implanted on (b)(6) 2017 and explanted on (b)(6) 2015.Follow-up is being conducted to obtain clarification on the discrepant information.There was no known impact or consequence to the patient.No further complications were reported/anticipated.
Additional Manufacturer Narrative
The lead was bent near the handle approximately 37 cm from the distal end.
Additional Manufacturer Narrative
Analysis of the lead (lot # va1cdnk) found that the #0 electrode was bent.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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
Additional information was received: it was reported that the new lead was implanted and old product explanted on (b)(6) 2017.Only the open lead wasn't implanted.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 6421496
• Report Number: 2649622-2017-02497
• Device Sequence Number: 474584
• Product Code: MHY
• UDI-Device Identifier: 00643169313538
• UDI-Public: 00643169313538
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 09/06/2019
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1CDNK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/27/2017; 09/13/2022
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/24/2017; 04/27/2017; 10/02/2017; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2016
• 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: 34 YR
• Patient Sex: Unknown