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

Model Number	3389S-40
Medical Device Problem Codes	Bent (1059); Break (1069); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information references the main component of the system, other applicable components are: product id: mi-1000, lot# 082618417, product type: accessory.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
Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that the lead would not feed into the measuring tool and was bent in the process.It was noted there was a possible blockage in the measuring tool.The set screw was checked and looked like it was backed out far enough.The physician used a new lead and was able to get it into the tool.The issue was resolved at the time of this report.No medical symptoms were reported.No further complications are anticipated.
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 facility.It was reiterated that when the lead was passed to the sterile field it became bent bent.However, the lead never reached the patient.No patient symptoms were alleged.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6886782
• Report Number: 2649622-2017-10202
• Device Sequence Number: 10921783
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2017

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: 05/16/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1J5Y2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 62