MAUDE Adverse Event Report: MPRI 8-4 EXTENSION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3708660
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
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 provider (hcp), via a manufacturing representative (rep), regarding a patient with an implantable neurostimulator (ins) for movement disorders.It was reported that there was an extension failure.There was no other information provided from the hcp.The rep noted that they would review impedances when they see the patient and hcp.The issue was not resolved at the time of the report.No patient symptoms or further complications were reported as a result of this event.(b)(6) 2019 e1 (rep): no additional information was received.
Additional Manufacturer Narrative
(b)(4).Based on registration information, the extension (serial number: (b)(4)) is a part of a mixed system as of (b)(6) 2019 using an implantable neurostimulator from another manufacturer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated the patient was experiencing a loss of therapy.They tried to program around but had since come back with a continued loss of therapy.It was indicated surgery would now need to be performed to change the extension.The cause for the failure was unknown.The issue was not resolved at the time of the report.

• Brand Name: 8-4 EXTENSION
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8638287
• Report Number: 2649622-2019-08878
• Device Sequence Number: 1992062
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2021
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR