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

Model Number	3708660
Medical Device Problem Codes	High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Electric Shock (2554)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for off label indication.Ins was non-medtronic.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the rep received an email from an hcp on 2020-feb-14.The email stated an intra-operative impedance test had been scheduled for (b)(6) 2020.The patient had a lead from this manufacturer and a ins from boston scientific.It was unknown when the patient changed to a boston scientific ins.More information would be available on 2020-feb-25.No symptoms were reported.No further complications were reported/anticipated.Additional information was received indicating the patient would feel shocking every time they moved their head.An intra op impedance check was conducted with alligator clips and found the impedances were high at the extension and within normal range at all contacts on the lead.The extension was replaced, as well as the ins and the impedances were normal.
Additional Manufacturer Narrative
Concomitant medical products: product id: 3387-40, lot# : v001105, implanted: (b)(6) 2006: product type: lead.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the extension, s/n: (b)(4), found no anomalies.If information is provided in the future, a supplemental report will be issued.

• 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: 9763290
• Report Number: 2649622-2020-04102
• Device Sequence Number: 19004835
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2020

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: 05/15/2022
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 05/13/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/26/2020; 05/13/2020
• 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 Weight: 70