MAUDE Adverse Event Report: MPRI ACTIVA

Model Number	3708640
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/09/2021
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
It was reported that patient was complaining of being ¿shocked¿ on his left scalp where brain lead and scalp join.Although impedances were within normal limits the surgeon made the decision to replace the extension with a new extension.Intra op, impedances showed a short at 1 and 3 and they changed the programming to contact 2 with good therapeutic response.External factors that may have contributed were not reported or were unknown.Issue was reported to be resolved at time of report.

• Brand Name: ACTIVA
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11668649
• Report Number: 2649622-2021-07302
• Device Sequence Number: 3049510
• Product Code: MHY
• UDI-Device Identifier: 00643169449145
• UDI-Public: 00643169449145
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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: 03/17/2021
• Device Model Number: 3708640
• Device Catalogue Number: 3708640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 04/14/2021
• 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: 81 YR