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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Inflammation (1932); Meningitis (2389); Loss of consciousness (2418); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 01/28/2022

Event Type  Injury  

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_ext, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_unknown_ext, serial/lot #: unknown; product id: neu_unknown_lead, serial/lot #: unknown.This value is the average age 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.If information is provided in the future, a supplemental report will be issued.

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 methicillin-sensitive staphylococcus aureus, 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: a (b)(6) female patient with parkinson¿s disease initially underwent bilateral globus pallidus internus (gpi) electrode placement.On postoperative day (pod) 20, she developed redness along the neck under the dbs connector site and was found to have a subdural empyema growing enterobacter; therefore, the system was removed 20 days after implantation.Ninety-one days after reimplantation, the patient developed an extracranial scalp infection with enterobacter (with the same sensitivities as the initial infection), so again the system was removed.A (b)(6) male patient with parkinson¿s disease underwent bilateral gpi lead implantation.He fared very well with clean wounds at the 2-week postoperative visit and had improvement in his parkinson¿s symptoms.His condition acutely deteriorated on pod 30 with seizures, unresponsiveness, and meningitis.An initial ct scan showed left frontal brain edema but no enhancement.At surgery, the burr hole was draining pus; therefore, the entire system was removed on pod 30.A ct scan 7 days post-explant showed cerebritis, left greater than right.The meningitis and cerebritis were secondary to (b)(6) and were treated with nafcillin for 6 weeks.His system was reimplanted 270 days after the explant.He then developed an extracranial scalp mssa infection with the same sensitivities as the initial infection.The entire system was removed again 36 days after the reimplantation.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: 13891650
• MDR Text Key: 293149072
• Report Number: 2182207-2022-00498
• 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: 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: 65 YR