MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37601
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: extension.Product id: 3387s-40, lot#: va1s607, implanted: (b)(6) 2018, explanted: (b)(6) 2020.Product type: lead.Product id: 3387s-40, lot#: va1rb0c, implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.Product id: 3387s-40, lot#: va1rb0c, implanted: (b)(6) 2018, product type: lead.Product id: 3387s-40, lot#: va1s607, implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead.Other relevant device(s) are: product id: 3387s-40, serial/lot #: (b)(4), ubd: 03-apr-2021, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(4), ubd: 27-feb-2021, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(4), ubd: 27-feb-2021, udi#: (b)(4).Product id: 3387s-40, serial/lot #: (b)(4), ubd: 03-apr-2021, udi#: (b)(4).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 manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had a full system explant due to suboptimal lead location.The new battery and lead were being placed (b)(6) 2020.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10970039
• Report Number: 3004209178-2020-21419
• Device Sequence Number: 2539479
• Product Code: MHY
• UDI-Device Identifier: 00643169100770
• UDI-Public: 00643169100770
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 01/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/08/2020
• 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