MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PERCEPT; Stimulator, electrical, implanted, for parkinsonian tremor

Model Number B35200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erythema (1840); Unspecified Infection (1930); Pain (1994); Seroma (2069); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_lead, lot# unknown.Product type lead.Other relevant device(s) are: product id: neu_unknown_lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a patient with parkinson's disease managed with medication had their dbs placed (b)(6) 2021.They had  persistent generator pocket infection and with tenderness and erythema of the skin overlying the leads at leastto the level of the posterior neck/posterior auricular region.The generator and a portion of the leads connecting from the generator to the temporal scalp were removed with cultures growing (serratia marcescens).They now had reimplantation of hardware in the same site, and on suppressive levofloxacin given retained leads from the right temporal scalp into brain tissue.They were noted to have fluctuance at the ins site and prescribed one week of keflex.On (b)(6) 2021 the fluid collection resolved.On (b)(6) 2021 there was recurrent fluid collection over the right chest and were prescribed one week of keflex, resolving the issue.On (b)(6) 2021 there was a 3rd episode of right anterior chest wall swelling and warmth.Fluid expressed from site and was sent for culture.This time, keflex did not help and cx grew serratia marcescens.On (b)(6) 2021 they were admitted for right chest generator site infection with a new lead tunneling site pain posterior to right ear.On (b)(6) 2021, or for right chest washout, battery removal, and wound closure.They found serosanguinous fluid in right chest wall pocket.On (b)(6) 2021, noted to be growing serratia and s.Hemolyticus from generator and paenibacillus (which was sent to micro from operating room).On (b)(6) 2021,  or for removal of dbs lead extension from the right parietal region with wound washout and closure.On (b)(6) 2021 residual fluid pocket in chest drained.On (b)(6) 2021, discharged from hospital on 4 weeks cefepime.On (b)(6) 2021 the patient was doing well, cefepime stopped and picc line removed.On (b)(6) 2021 admitted for reimplantation of hardware, given cefepime in perioperative period.They were discharged with plans for suppressive levofloxacin given retention of some of his initial hardware, extended suppression planned for at least one year.

• Brand Name: PERCEPT
• Type of Device: Stimulator, electrical, implanted, for parkinsonian tremor
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16391096
• MDR Text Key: 309732276
• Report Number: 2182207-2023-00290
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B35200
• Device Catalogue Number: B35200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR