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

Model Number	37603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Swelling (2091)
Date of Event	09/15/2017
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
Information was received from a healthcare provider (hcp) of a clinical study regarding a patient with an implantable neurostimulator (ins).It was reported the patient had an infection complication that resulted in prolonged hospitalization.The patient had a head ct performed that showed mild soft tissue swelling and induration along their left postauricular area and temporoparietal scalp along the course of the prior electrode are indicative of soft infection/cellulitis without abscess.There was no evidence of osteomyelitis in the adjacent calvarium.They underwent a scalp washout several days later.Their incision had since healed.No further complications were reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.There was a washout of the lead on (b)(6) 2017 to make sure there was no evidence of osteomyelitis in the adjacent calvarium.The event date was updated from (b)(6) 2018 to (b)(6) 2018.It was also reported that the infection occurred in the left postauricular area and temporoparietal scalp.Etiology was updated to the event being possibly related to the implant procedure.No further complications were reported.
Additional Manufacturer Narrative
Previous reports were not system reported.Additional review noted that the lead was part of a system at the time of the event.Updated information to reflect ins information which was the main component of the system.Product id: 3389s-40, lot# va0y1qu, implanted: (b)(6) 2015, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was implanted for parkinson's dual and movement disorders.
Additional Manufacturer Narrative
Additional review of this event determined that information regarding explant and re-implant was erroneously reported in mfr report number: 3007566237-2018-03241 and belongs in this mfr report.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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8006671
• Report Number: 2649622-2018-17532
• Device Sequence Number: 13778542
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Device Lot Number: VA0Y1QU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 03/28/2019; 03/27/2019
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/07/2018; 03/28/2019; 04/04/2019
• 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: 65 YR