MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION

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

Patient Problem No Code Available (3191)

Event Date 11/29/2019

Event Type  Injury  

Event Description

A report was received that the patient underwent an explant procedure of the stimulator.The reason of the explant is unknown.No other information is available.

Event Description

A report was received that the patient underwent an explant procedure of the stimulator.The reason of the explant is unknown.No other information is available.Additional information was received that the reason for the explant was that the patient was in need of an mri due to a pending hip replacement procedure.It was also noted that the patient had not used the stimulation system for 18 months.The devices were discarded by the facility.

• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9477746
• MDR Text Key: 171580797
• Report Number: 3006630150-2019-07390
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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: 11/29/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention