MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. INFINION 16; STIMULATOR, SPINAL CORD, TOTALLY IMPLANT

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2018

Event Type  Injury  

Event Description

Leads from spinal cord stimulator trial broke off of lead catheter in patient during placement.

• Brand Name: INFINION 16
• Type of Device: STIMULATOR, SPINAL CORD, TOTALLY IMPLANT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 7934115
• MDR Text Key: 122886278
• Report Number: MW5080340
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 62 YR