MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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

Patient Problems Unspecified Infection (1930); Paralysis (1997); Sepsis (2067)

Event Date 10/05/2021

Event Type  Injury  

Event Description

It was reported that after undergoing a spinal cord stimulator scs implant procedure, the patient became septic and contracted an infection along the spine.The patient was unable to walk and control her bowel and bladder movements.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding this event and the patient outcome.

• 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: 12713923
• MDR Text Key: 278980739
• Report Number: 3006630150-2021-06044
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/28/2021

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/28/2021
• 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): Other