MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM(TM) DRG NEUROSTIMULATOR SYSTEM; DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF

Device Problem Energy Output Problem (1431)

Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Chills (2191); Malaise (2359); Lethargy (2560); Unspecified Gastrointestinal Problem (4491)

Event Date 10/28/2022

Event Type  Injury  

Event Description

A 74 year old female patient had a temporary drg neurostimulator device implanted as a seven-day trial to relieve neuropathy in the lower extremities.The evening before the implant was to be removed, patient increased the stimulation provided by the device by 2 levels with the approval of the doctor and device manufacturer representative.Soon after, the patient felt an uncomfortable sensation of electrical current on her tongue, similar to the sensation of "placing a 9- volt battery to your tongue." she immediately decreased the stimulation of the device by 1 level, which did not relieve the sensation.She then decreased the stimulation level by 1 level again, which also did not relieve the reaction.Finally, she turned the device off completely, and the adverse sensations ceased.Later that night, the patient experienced sudden chills, an increased body temperature that measured 98.6*f, which is about 1*f higher than her typical temperature.The implants were removed on schedule, but the patient continued to have chills, felt lethargic, had general malaise, and continued to run a higher than normal temperature along with nausea and discomfort upon eating x 4 days.The patient was given a prescription for cephalexin 500mg by mouth twice daily for 7 days, which she started on the evening of the device removal.On the day before the device was removed, the patient had an endoscopy and colonoscopy exam performed.Fda safety report id# (b)(4).

• Brand Name: PROCLAIM(TM) DRG NEUROSTIMULATOR SYSTEM
• Type of Device: DORSAL ROOT GANGLION STIMULATOR FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 15715375
• MDR Text Key: 302931106
• Report Number: MW5113011
• 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: 10/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 0.5% NITROGLYCERIN OINTMENT; AMLODIPINE 10 MG ; FISH OIL 3000 MG; FUROSEMIDE 20 MG ; MELATONIN 10 MG ; OXYBUTYNIN 5 MG B.I.D. ; POTASSIUM 20 MEQ ; PROBIOTIC SUPPLEMENT ; SIMVASTATIN 20 MG ; SPIRONOLACTONE 25 MG ; VITAMIN D 1200
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White