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

Model Number NEU_INS_STIMULATOR

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

Patient Problems Wound Dehiscence (1154); Erosion (1750); Purulent Discharge (1812); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Discomfort (2330); Alteration In Body Temperature (2682)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: neu_unknown_ext, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Product id: neu_ins_stimulator, serial/lot #: unknown.Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event: 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.Description of problem or event: 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

Atchley tj, laskay nmb, sherrod ba, rahman a, walker hc, guthrie bl.Reoperation for device infection and erosion following deep brain stimulation implantable pulse generator placement.J neurosurg.2019:1-8.10.3171/2019.3.Jns183023.Summary: infection and erosion following implantable pulse generator (ipg) placement are associated with morbidity and cost for patients with deep brain stimulation (dbs) systems.Here, the authors provide a detailed characterization of infection and erosion events in a large cohort that underwent dbs surgery for movement disorders.Reported events: 13 patients required ipg hardware removal due to infection within one year of implant.1 patient required ipg hardware removal due to infection one year beyond one year of implant.The infection was most likely related to the surgery itself and/or wound closure.The authors noted the use of vancomycin powder during stage 2 procedure did not decrease rate of hardware infection.27 patients required part or all of the extension wire to be removed due to infection.5 patients required ipg hardware removal due to coagulase-negative staphylococci.5 patients required ipg hardware removal due to pseudomonas aeruginosa.2 patients developed a second infection requiring a second re-operation on the same side.2 patients developed a third infection requiring a third re-operation on the same side.11 patients required ipg hardware removal due to erosion within one year of implant.1 patient required ipg hardware removal due to erosion one year beyond one year of implant.The erosion was related to chronic changes associated with friction, poor cushioning from the overlying soft tissue, or other patient-related factors.The authors noted that bmi was inversely related to the frequency of erosion.4 patients with required ipg hardware removal due to erosion, also associated with concomitant infection.The following device specifics were identified in the literature article: ins model 37601, 37602, 37603, and 7426.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8849053
• MDR Text Key: 152923190
• Report Number: 3007566237-2019-01679
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2019

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
• 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
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/31/2019
• 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: 60 YR