MAUDE Adverse Event Report: UNKNOWN UNKNOWN LEAD; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Lot Number 3851ANS

Device Problem Difficult to Insert (1316)

Patient Problems Headache (1880); Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

It was reported in an article (simopoulos, t.T., sharma, s., aner, m., gill, j.S.The incidence and management of postdural puncture headache in patients undergoing percutaneous lead placement for spinal cord stimulation.Neuromodulation: journal of the international neuromodulation society.2016.Doi: 10.1111/ner.12445) that a 38-year-old female undergoing spinal cord stimulation (scs) trial for failed back surgery syndrome (fbss) experienced a postdural puncture headache (pdph) from a t12/l1 level dural puncture 5 days after the placement of a temporary trial lead.The patient's medical records reportedly documented accidental intrathecal access during insertion of the trial lead.The pdph did not respond to conservative non-interventional treatments, including bed rest, iv fluids, and analgesics of at least 24 hours duration and ultimately underwent an epidural blood patch.It was noted that there was enough time for the patient to determine that the trial was beneficial before onset of the headache, and the patient made a full recovery following the blood patch (minimum follow up of one year) with no documented long-term sequelae.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN LEAD
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17531840
• MDR Text Key: 321144395
• Report Number: MW5138751
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

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?: No
• Device Lot Number: 3851ANS
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1