MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

Device Problem Use of Device Problem (1670)

Patient Problems Depression (2361); Coma (2417); Convulsion/Seizure (4406)

Event Date 01/18/2021

Event Type  Injury  

Event Description

A report was received through social media that an unconfirmed patient underwent a surgery that was supposed to take 3 hours but ended up taking 7 hours.It was also posted that he was intubated and put into a coma, had seizures, cut his throat in an attempt to commit suicide and was hospitalized in a mental hospital.The patient was diagnosed by a therapist with ptsd due to the trauma from the surgery.The patient was advised to turn the stimulator off.No further information can be obtained.

• Manufacturer (Section D): 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: 11287720
• MDR Text Key: 230557783
• Report Number: 3006630150-2021-00316
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2021
• 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): Hospitalization; Other; Required Intervention