MAUDE Adverse Event Report: ABBOTT MEDICAL DRG IMPLANT; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Model Number 3664 WITH MN10450-50A

Patient Problems Air Embolism (1697); Headache (1880); Failure of Implant (1924); Muscle Weakness (1967); Pain (1994); Inadequate Pain Relief (2388); Numbness (2415); Weight Changes (2607); Blister (4537)

Event Type  Injury  

Event Description

During my trial drg implant it overheated multiple times causing burn blistery on my back, then they had to have emergency removal.A month later a permanent was implanted, between causing more pain, sever migraines weakness and tingling in legs and arms not to mention weight lost because pain makes me not hungry.Implanting surgeon refused a followup appointment, stating there was nothing further he could do for me, without even seeing me.Va initially said the same thing but after complaining enough was referred to (b)(6) who did multiple separate myelograph scans finding a frayed electrode lead in my spinal cord and multiple pockets of air in my cerebral fluid.Multiple abbot reps came to my house to reprogram and then last abbot turned off due to the frayed lead ," so further damage was mitigated"; drg was explanted and now i've been in physical therapy every week for my severe migraines tingling legs, arms, chronic back and groin pain.Initially got drg due to y service connected disabilities i sustained while on active duty state side and in combat.All it did for me was cause more pain and problems.Current va primary care says meds are a bandaid so he refuses to prescribed pain medication.I wouldn't have got this done if i knew then what i feel now i'm 37 years old with sole custody of my 4 yr old son, and being told i'll never be pain free but need to find a way to manage.Reference report: mw5149570.

• Brand Name: DRG IMPLANT
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 18397935
• MDR Text Key: 331440761
• Report Number: MW5149571
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3664 WITH MN10450-50A
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: TRAMADOL
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Hispanic
• Patient Race: White