MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

Device Problem Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2020

Event Type  Injury  

Event Description

It was reported in a journal article by leonardo kapural, et al.(2015), titled 'novel 10-khz high-frequency therapy (hf10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain', there were five study-related adverse events observed, where multiple devices were revised due to lead migration.No identifying information was available but at least some of the devices appeared to have been manufactured by boston scientific.No additional information was provided.

• 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: 10160440
• MDR Text Key: 195365534
• Report Number: 3006630150-2020-02488
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/16/2020
• 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