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

Device Problem Difficult to Insert (1316)

Patient Problem 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 40-year-old female undergoing a spinal cord stimulation (scs) trial for interstitial cystitis experienced a postdural puncture headache (pdph) from an l4/5 level dural puncture 3 days after the placement of dual permanent trial leads.The patient's medical records reportedly documented difficult lead insertion.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 with hardware in situ.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: 17529759
• MDR Text Key: 321107699
• Report Number: MW5136683
• 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

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1