MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-30

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

Patient Problems Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891)

Event Date 04/12/2018

Event Type  Injury  

Event Description

A report was received that during the permanent implant procedure the patient developed intracranial hemorrhage which was severe.No action was taken and no other information is available.The event was assessed as having a causal relationship to the procedure and not related to the device or stimulation.

Manufacturer Narrative

Additional information was received that per clinical study protocol no additional information is available and no further information can be obtained regarding the study devices.

Event Description

A report was received that during the permanent implant procedure the patient developed intracranial hemorrhage which was severe.No action was taken and no other information is available.The event was assessed as having a causal relationship to the procedure and not related to the device or stimulation.

Manufacturer Narrative

Initial reporter name and address: phone:(b)(6).Additional information was received that the patient was extubated and showed diminished vigilance.A cct scan was performed and showed an intraventricular blood accumulation as well as a small hemorrhaging near the electrode.There was no evidence of space occupying hemorrhaging or ischemia.No action was taken and the patient improved with no signs of neurological deficit.

Event Description

A report was received that during the permanent implant procedure the patient developed intracranial hemorrhage which was severe.No action was taken and no other information is available.The event has assessed as having a causal relationship to the procedure and not related to the device or stimulation.

Manufacturer Narrative

Additional information was received that the event was assessed as having a probable relationship to the stimulation.

Event Description

A report was received that during the permanent implant procedure the patient developed intracranial hemorrhage which was severe.No action was taken and no other information is available.The event has assessed as having a causal relationship to the procedure and not related to the device or stimulation.

Event Description

A report was received that during the permanent implant procedure the patient developed intracranial hemorrhage which was severe.No action was taken and no other information is available.The event has assessed as having a causal relationship to the procedure and not related to the device or stimulation.Additional information was received that per clinical study protocol no additional information is available and no further information can be obtained regarding the study devices.Additional information was received that the patient was extubated and showed diminished vigilance.A cct scan was performed and showed an intraventricular blood accumulation as well as a small hemorrhaging near the electrode.There was no evidence of space occupying hemorrhaging or ischemia.No action was taken and the patient improved with no signs of neurological deficit.Additional information was received that the event was assessed as having a probable relationship to the stimulation.Additional information was received, the lead model and serial number were provided.The phone number of the facility is (b)(6).

Event Description

A report was received that during the permanent implant procedure the patient developed intracranial hemorrhage which was severe.No action was taken and no other information is available.The event has assessed as having a causal relationship to the procedure and not related to the device or stimulation.Additional information was received that per clinical study protocol no additional information is available and no further information can be obtained regarding the study devices.Additional information was received that the patient was extubated and showed diminished vigilance.A cct scan was performed and showed an intraventricular blood accumulation as well as a small hemorrhaging near the electrode.There was no evidence of space occupying hemorrhaging or ischemia.No action was taken and the patient improved with no signs of neurological deficit.Additional information was received that the event was assessed as having a probable relationship to the stimulation.Additional information was received, the lead model and serial number were provided.The phone number of the facility is (b)(6).

Manufacturer Narrative

E1: initial reporter phone: (b)(6).Additional suspect medical device component (s) involved in the event: product family: dbs-linear leads; upn: m365db2202300; model: db-2202-30; serial: (b)(6); batch: 7000713.

• Brand Name: VERCISE CARTESIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7526525
• MDR Text Key: 108667951
• Report Number: 3006630150-2018-01750
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905271
• UDI-Public: 08714729905271
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/27/2022

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: Lay User/Patient
• Device Expiration Date: 11/29/2019
• Device Model Number: DB-2202-30
• Device Catalogue Number: DB-2202-30
• Device Lot Number: 21443405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 05/25/2018; 11/23/2018; 08/15/2019; 05/18/2020; 03/31/2022
• Supplement Dates FDA Received: 06/08/2018; 12/11/2018; 09/03/2019; 06/03/2020; 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• 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; Other
• Patient Sex: Female