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

Model Number	3708660
Medical Device Problem Codes	High impedance (1291); Device Damaged Prior to Receipt by User (1570); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2019
Type of Reportable Event	Malfunction
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 manufacture representative (rep) regarding a patient who was implanted with an implantable neuro stimulator (ins) for essential tremor and movement disorders.It was reported that impedances on all combos with contact 3 were high because the lead could not seat properly in the connector.The surgeon attempted to advance lead in extension and was not able to pass all electrodes through.The surgeon re-opened set screws to make sure all were open enough to pass lead into extension connection but could not.A new extension was opened and re-tunneled, and the issue was resolved at the time of the report.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.

• Brand Name: DBS¿
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8399295
• Report Number: 2649622-2019-03809
• Device Sequence Number: 1827909
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: 10/08/2022
• 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: 03/05/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR