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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN UNKNOWN LEAD; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
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UNKNOWN UNKNOWN LEAD; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) Back to Search Results
Device Problem Insufficient Information (3190)
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 32-year-old female undergoing a spinal cord stimulation (scs) trial for left upper extremity complex regional pain syndrome (crps) experienced a postdural puncture headache (pdph) from a t2/3 level dural puncture 4 days after the placement of the permanent trial lead.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).
 
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Brand Name
UNKNOWN LEAD
Type of Device
STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
Manufacturer (Section D)
UNKNOWN
MDR Report Key17534597
MDR Text Key321146949
Report NumberMW5141498
Device Sequence Number1
Product Code GZB
Combination Product (y/n)N
Number of Events Reported1
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 Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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