MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146); Insufficient Information (4580)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that a non confirmed patient mentioned that a spinal cord stimulator (scs) device was implanted in the reproductive area and felt electrocuted from the ankle to the neck.This resulted to sudden loss of speech and loss of appetite.It was also mentioned that something had exploded from the reproductive area to the throat and cranium.After the equipment exploded a few times, the patient felt her throat to the airway was being cut off.The patient noticed being sick to the stomach daily with no appetite and presented in the emergency room (er) and was referred to an ear, nose, and throat (ent) doctor wherein she was diagnosed with (b)(6) infection.The patient also had severe shoulder pain that looked cellulitic.Synovial arthrocentesis was done and patient was then prepared for right shoulder sub acromial and debridement.Following the procedure, patient was verified to have a (b)(6) infection.The patient further noted that she underwent an unknown surgery wherein something was retained and believed that it was how she got the infection that was causing the septic arthritis.Patient was prescribed with cefazolin and had a picc line.

• 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: 14599035
• MDR Text Key: 293338015
• Report Number: 3006630150-2022-02691
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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
• Date Manufacturer Received: 05/05/2022
• 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