MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; DEEP BRAIN STIMULATOR

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

Patient Problems Edema (1820); Hematoma (1884); Brain Injury (2219); Confusion/ Disorientation (2553)

Event Date 03/07/2018

Event Type  Injury  

Event Description

A report was received that the patient developed an intraparenchymal hematoma during lead placement.The patient appeared drowsy with confused spells.A head ct scan was performed and showed a hyperdense juxta and subcortical blood collection with moderate edema along the intracerebral electrode in the right hemisphere.The patient had a subsequent head ct scan that showed improvements in the brain lesion through to complete resolution but a gradual worsening in the cerebral edema, for which steroid therapy was introduced.The physician decided to put off switching on the stimulator until the cerebral edema had been resolved.A millimetric hyperdensity around the right electrode was reveal.

Event Description

A report was received that the clinical study patient developed an intraparenchymal hematoma during lead placement.The patient appeared drowsy with confused spells.A head ct scan was performed and showed a hyperdense juxta and subcortical blood collection with moderate edema along the intracerebral electrode in the right hemisphere.The patient had a subsequent head ct scan that showed improvements in the brain lesion through to complete resolution but a gradual worsening in the cerebral edema, for which steroid therapy was introduced.The physician decided to put off switching on the stimulator until the cerebral edema had been resolved.A millimetric hyperdensity around the right electrode was revealed, associated with a large area of edematous hypodensity, which later regressed.The patient was discharged and was lucid, syntonic, good motor compensation with stimulation off in the evening.According to the physician the event is resolved.

• Brand Name: NI
• Type of Device: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7680106
• MDR Text Key: 113737050
• Report Number: 3006630150-2018-02267
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: 150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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