MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PRIMARY CELL IPG; DEEP BRAIN STIMULATOR

Model Number DB-1140

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

Patient Problems Neurological Deficit/Dysfunction (1982); Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 09/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Suspect medical device components involved in the event: model: db-2202-30, serial: (b)(4), description: dbs directional lead sterile kit, 30cm.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient was admitted due to increasing gait disorder with significant deterioration in ability to walk which was moderate in severity.It was noted that the patient had been on a long cycling tour and from laboratory results, the constellation of a rhabdomyolysis, became apparent and gradually improved with rest, and fluids, both orally and intravenously.The patients device and medications were adjusted and a significant improvement in movement was seen.The patient and the event have recovered and resolved and the patient was discharged.The event was assesses as probably related to the study stimulation and not related to the procedure or device.

Event Description

A report was received that the patient was admitted due to increasing gait disorder with significant deterioration in ability to walk which was moderate in severity.It was noted that the patient had been on a long cycling tour and from laboratory results, the constellation of a rhabdomyolysis, became apparent and gradually improved with rest, and fluids, both orally and intravenously.The patients device and medications were adjusted and a significant improvement in movement was seen.The patient and the event have recovered and resolved and the patient was discharged.The event was assesses as probably related to the study stimulation and not related to the procedure or device.

Manufacturer Narrative

Correction to follow up 05/15/2018.

Event Description

A report was received that the patient was admitted due to increasing gait disorder with significant deterioration in ability to walk which was moderate in severity.It was noted that the patient had been on a long cycling tour and from laboratory results, the constellation of a rhabdomyolysis, became apparent and gradually improved with rest, and fluids, both orally and intravenously.The patients device and medications were adjusted and a significant improvement in movement was seen.The patient and the event have recovered and resolved and the patient was discharged.The event was assesses as probably related to the study stimulation and not related to the procedure or device.

• Brand Name: VERCISE PRIMARY CELL IPG
• 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: 7507570
• MDR Text Key: 108016248
• Report Number: 3006630150-2018-01667
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2018

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
• Device Expiration Date: 09/30/2017
• Device Model Number: DB-1140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 04/16/2018; 04/16/2018
• Supplement Dates FDA Received: 05/15/2018; 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2015
• 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): Hospitalization; Required Intervention