MAUDE Adverse Event Report: ST. JUDE MEDICAL TWELVE ELECTRODE 60 CM PERMANENT LEAD; SPINAL CORD STIMULATOR

Model Number 1124-60

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 01/24/2018

Event Type  malfunction  

Event Description

Piece of lead electrode broke off in patient after inserting.Unable to retrieve the piece.Had pulled lead out to reposition when noticed the piece was missing.Could see via imaging it was left behind.Another lead placed successfully.Dates of use: (b)(6) 2018.Diagnosis or reason for use: medically intractable neuropathic pain.

• Brand Name: TWELVE ELECTRODE 60 CM PERMANENT LEAD
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 7244412
• MDR Text Key: 99208746
• Report Number: MW5075071
• Device Sequence Number: 1
• Product Code: GZB
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1124-60
• Device Lot Number: 104070440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 55 YR