Model Number DB-2202-45 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914); Rash (2033); Impaired Healing (2378)
|
Event Date 09/29/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional suspect medical device component involved in the event: product family: dbs-lead fixation upn: m365db4600c0 model: db-4600c serial: n/a batch: 31666133.
|
|
Event Description
|
It was reported that the deep brain stimulation (dbs) patient developed an infection at the right lead site.There was discoloration and abnormal healing at the site.The physician indicated that the burr hole cover is high profile and contributed to the infection.The patient underwent an explant of the lead and burr hole cover (bhc).The patient remained as an inpatient to be monitored and receive antibiotics.While hospitalized, the patient underwent a computer tomography (ct) scan and experienced an allergic reaction the dye.The patient was later discharged.The patient later returned to the medical facility due to low blood pressure.
|
|
Manufacturer Narrative
|
Additional suspect medical device component involved in the event: product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600c.Serial: n/a.Batch: 31666133.
|
|
Event Description
|
It was reported that the deep brain stimulation (dbs) patient developed an infection at the right lead site.There was discoloration and abnormal healing at the site.The physician indicated that the burr hole cover is high profile and contributed to the infection.The patient underwent an explant of the lead and burr hole cover (bhc).The patient remained as an inpatient to be monitored and receive antibiotics.While hospitalized, the patient underwent a computer tomography (ct) scan and experienced an allergic reaction the dye.The patient was later discharged.The patient later returned to the medical facility due to low blood pressure.Additional information was received that the patient was diagnosed with drug reaction with eosinophilia and systemic symptoms (dress).The patient symptoms were related to an immune response to antibiotics.
|
|
Search Alerts/Recalls
|