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 Wound Dehiscence (1154); Intracranial Hemorrhage (1891); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Product id: neu_ins_stimulator, serial#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown; product id: neu_ins_stimulator, serial/lot #: unknown.Age: 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.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

Deshpande, n., gibbs, r., ali, r.Evaluation of dbs timeline in movement disorders: a comparison between genders.World neurosurgery (2022).Doi: 10.1016/j.Wneu.2022.Summary: background: deep brain stimulation (dbs) is a pivotal surgical treatment for movement disorders.However, men and women have had differing opinions and referral experiences related to dbs, leading us to assess whether a gender disparity exists in the interval from a movement disorder diagnosis to dbs usage.- methods: we performed a single-center, retrospective cohort study of 105 patients who had undergone dbs surgery for either parkinson disease (pd) or essential tremor (et).We compared the gender differences in the median interval from the diagnosis date, dbs consultation date, and dbs surgery dates.Additionally, the patient demographics, baseline clinical characteristics, and dbs outcomes were compared between men and women.- results: we found no significant differences between genders in the interval from the diagnosis to dbs surgery for et or pd.At the dbs consultation for et, the women had had significantly greater disease severity compared with the men (p [ 0.029).The baseline motor impairment without medication was similar between the men and women with pd.However, female patients with pd had experienced a significantly greater reduction compared with male patients in baseline motor impairment with medication versus without medication (p [ 0.042).No minority populations were represented within the female et and pd subgroups.- conclusions: our study detected no gender differences in the dbs implantation timeline but alluded to a gender-specific discrepancy in the dbs referral for et.The female patients did not have a shorter duration from the et diagnosis to dbs, despite experiencing significantly greater baseline et severity compared with their male counterparts.Furthermore, the women with et more often used medicaid insurance and were without minority representation.Reported events: 1.Of the 105 patients analyzed, 13 (5 men and 8 women) had experienced some form of complication secondary to dbs surgery.The specific complications that were device related included 7 patients who experienced persistent wound dehiscence at the incision site.Of the 7 patients with chronic wound dehiscence, 3 had required removal of the existing dbs system and underwent subsequent reimplantation.2.Intraparenchymal hemorrhage occurred in 3 patients and of the 3 patients with intraparenchymal hemorrhage, 2 were asymptomatic and 1 had developed permanent right-sided motor deficits.3.Postoperative cerebral edema with sub sequent status epilepticus occurred in 1 patient.

• 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: 14649775
• MDR Text Key: 294848441
• Report Number: 2182207-2022-01040
• 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: 06/09/2022

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: 05/12/2022
• Initial Date FDA Received: 06/09/2022
• 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: 69 YR
• Patient Sex: Female