MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI

Model Number NEU_INS_STIMULATOR

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

Patient Problem Bacterial Infection (1735)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Philipp spindler, katharina faust, tobias finger, gerd-helge schneider, simon bayerl, andrej trampuz, andrea a.Kühn, peter vajkoczy, vincent prinz.High frequency of low-virulent microorganisms detected by sonication of implanted pulse generators: so what? doi: 1 0.1159/000517472 abstract introduction: deep brain stimulation (dbs) has become a well-established treatment modality for a variety of conditions over the last decades.Multiple surgeries are an essential part in the postoperative course of dbs patients if nonrechargeable implanted pulse generators (ipgs) are applied.So far, the rate of subclinical infections in this field is unknown.In this prospective cohort study, we used sonication to evaluate possible microbial colonization of ipgs from replacement surgery.Methods: all consecutive patients undergoing ipg replacement between may 1, 2019 and november 15, 2020 were evaluated.The removed hardware was investigated using sonication to detect biofilm-associated bacteria.Demographic and clinical data were analyzed.Results: a total of 71 patients with a mean (±sd) of 64.5 ± 15.3 years were evaluated.In 23 of these (i.E., 32.4%) patients, a positive sonication culture was found.In total, 25 microorganisms were detected.The most common isolated microorganisms were cutibacterium acnes (formerly known as propionibacterium acnes) (68%) and coagulase-negative staphylococci (28%).Within the follow-up period (5.2 ± 4.3 months), none of the pati ents developed a clinical manifest infection.Discussions/conclusions: bacterial colonization of ipgs without clinical signs of infection is common but does not lead to manifest infection.Further larger studies are warranted to clarify the impact of low-virulent pathogens in clinically asymptomatic patients.Reported events: it was reported that 5 patients had their ins' explanted to investigate bacteria cultures.Four low-virulent pathogens were found, with the most common pathogen being cutibacterium acnes.Others included coagulase-negative staphylococci, staphylococci sacchoarolyticus, staphylococci hominis and staphylococci haemolyticus.No patient developed surgical site infection or systemic infection.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI
• 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: 12981287
• MDR Text Key: 286764898
• Report Number: 2182207-2021-02150
• Device Sequence Number: 1
• Product Code: PJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male