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

Model Number	3708660
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
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 via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for essential tremor.It was reported that high impedance was noticed on the extension on contact 0 during stage 2 intraoperative impedance check.Unknown if any environmental/external/patient factors that may have led or contributed to the issue.Diagnostics/troubleshooting included extension being disconnected and wiped clean on both the lead extension and battery insertion portion of the extension and reinserted.It still was showing a higher impedance on contact 0.Interventions/actions included getting a new extension and using that and it showed no problems with impedances so they implanted the new extension.The issue is reported to be resolved.The extension is in the possession of the hospital but is expected to be returned.No symptoms were reported.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis of the extension (serial #: (b)(4)) revealed the extension had no anomalies associated with the device.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.
Event or Problem Description
Additional information received from the manufacturer¿s representative (rep), which was confirmed with the healthcare facility, reported there was no known reason for the high impedances.The extension was still at the hospital and waiting on paperwork for release to the manufacturer.No patient symptoms or further complications were anticipated.

• 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: 8378451
• Report Number: 2649622-2019-03345
• Device Sequence Number: 18887650
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• 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,Followup
• Report Date (Section B): 08/30/2019

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: 10/03/2022
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/12/2019; 08/13/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/24/2019; 08/30/2019
• 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
• Patient Weight: 109