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 Problems Bacterial Infection (1735); Cellulitis (1768); Headache (1880); Hypoglycemia (1912); Seroma (2069); Ulcer (2274); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/28/2022

Event Type  Injury  

Event Description

Moser, m., chitta, s., o'brien, p., caras, a., holloway, k.Recrudescent infection after deep brain stimulator reimplantation.Journal of neurosurgery.2022.Doi: 10.3171/2021.11.Jns211425.Summary: objective the efficacy of deep brain stimulation (dbs) in treating the symptoms of movement disorders can be life changing for patients.Thus, the 5%¿15% incidence of stimulator-related infection requiring removal of the device can be particularly disheartening.Although dbs system reimplantation is generally successful, this is not always the case.The literature is replete with publications describing the incidence of infection and the associated features.However, the literature is sparse in terms of information on the incidence of recurrent or recrudescent infection after system reimplantation.The goal of this paper was to evaluate factors leading to unsuccessful reimplantation of a dbs system following initial infection.Methods data were reviewed for all dbs procedures performed by one surgeon (k.L.H.) over 19 years including the infectious agent, location of infection, treatment regimen, and subsequent reimplantation of a dbs system and long-term outcome.Results in this series of 558 patients who had undergone dbs surgery, 37 (6.6%) subsequently developed an infection.Infections with (b)(6), enterobacter species, or coagulase-negative staphylococci were predominant.Four patients had cerebritis, one had meningitis, and the rest had soft tissue infections of the pocket or scalp.All had their entire dbs system explanted, followed by 4¿6 weeks of intravenous antibiotics and surveillance for recrudescence for an additional period of at least 30 days.Twenty-five patients subsequently underwent dbs system reimplantation, and the procedure was successful in 22.Three of the 4 patients with cerebritis developed subsequent wound infection after system reimplantation.None of the other 22 patients developed a recurrence.The odds ratio for developing a recurrent infection after cerebritis was 28.5 (95% ci 1.931¿420.5, p = 0.007).Conclusions this study, the largest series of dbs system re-implantations following infection, demonstrated that most patients can have successful re-implantations without recurrent infection.However, patients who have had dbs related cerebritis have a nearly 30-fold increased risk of developing reinfection after reimplantation.Alternative strategies for these patients are discussed.Reported events: 1.A (b)(6) male patient with essential tremor underwent bilateral ventral intermediate nucleus (vim) lead implantation.On pod 42, he had headaches, facial swelling, and fluid collection under the right burr hole.Ct scanning at that time demonstrated a 2.6 × 2.1 × 3¿cm, round, rim-enhancing lesion in the right frontal lobe adjacent to the dbs lead.The previous incisions and burr holes were reopened and copiously irrigated, and the entire system was removed.Surgical drainage of the intracranial cerebritis was not required.Staphylococcus epidermidis was identified, and the patient was treated with vancomycin for 6 weeks.Serial scans revealed resolution of the cerebritis.Mri with and without contrast was performed 10 months after the explant, revealing no evidence of residual intracranial infection.The patient underwent system reimplantation, then developed an mssa abscess over the right scalp 21 days after the reimplantation; thus, the system was again removed.2.A (b)(6) male patient with essential tremor under went left vim dbs system implantation.Nine days later, he developed cellulitis in the left chest implantable pulse generator (ipg)site, which grew serratia marcescens.The patient developed meningitis symptoms with negative csf cultures but elevated csf wbcs and low csf glucose.He underwent full explantation of the system along with wound washout.He was treated with 4 weeks of iv ceftriaxone and oral metronidazole.His system was reimplanted 4 months later, with cefazolin and gentamicin used as the perioperative antibiotics.

Manufacturer Narrative

Concomitant medical products: product id neu_unknown_ext , serial#: unknown, product type :extension; product id neu _unknown_lead ,lot# unknown, product type: lead; product id neu_ins_stimulator ,serial#: unknown , product type: implantable neurostimulator; product id: neu_unknown_ext serial#: unknown, product type: extension; product id: neu_unknown_lead, lot# unknown, product type: lead.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown ; product id: neu_ins_stimulator, serial/lot #: unknown.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 [or the date that the article was accepted for publication] as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.See related report #: 2182207-2022-00498 and 2182207-2022-00499.If information is provided in the future, a supplemental report will be issued.

• 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: 13891738
• MDR Text Key: 287842518
• Report Number: 2182207-2022-00500
• Device Sequence Number: 1
• Product Code: PJS
• 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: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• 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: 55 YR
• Patient Sex: Male