MAUDE Adverse Event Report: MPRI; 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	04/08/2019
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 a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).It was reported that the high impedance on all contact 1 combos, either 10k or 20k.Unknown if any environmental/external/patient factors that may have led or contributed to the issue.Diagnostics/troubleshooting included repeating impedance testing at various voltages primarily 1.5 and 3.0.Interventions/actions included replacing with another extension.The issue is reported to be resolved.During stage 2 battery and extension implant case, the leftside contact 1 had high impedances when ins was placed completely in pocket.When only partially inserted all impedances were okay.Surgeon decided to replace left extension only and impedances were okay even when fully inserted into pocket.No symptoms were reported.No further complications were reported or anticipated.
Additional Manufacturer Narrative
Analysis of the extension (serial # nkn198678v) revealed the body conductor was broken less than 5 cm from the proximal end.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the manufacturer representative (rep) reporting the cause of the high impedance was not determined, however the distal end (near battery port) should be closely examined as this seemed as this seemed to be the area of the most manipulation during pocket insertion.It was mentioned that they need to determine if bending the extension near battery connector block caused high impedance.

• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8504505
• Report Number: 2649622-2019-06160
• Device Sequence Number: 1846128
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 09/05/2022
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1617-2015
• Patient Sequence Number: 1
• Patient Age: 49 YR