MAUDE Adverse Event Report: ABBOTT MEDICAL ST JUDE MEDICAL ABBOTT NEUROSTIMULATOR TRIAL WITH LUMBAR BURST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 3086

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Weakness (2145); Numbness (2415)

Event Date 03/21/2019

Event Type  Injury  

Event Description

Pt underwent a (b)(6) trial on 03/21/2019, however, when pt woke up from procedure and was in recovery room, pt reported to nurse severe numbness and heaviness in both lower extremities and unable to move legs.The leads had been removed due to severe numbness and heaviness in pt's bilateral lower extremities.Pt had been sent to the hosp emergency room and had been admitted for approx 7 days.Pt has been diagnosed with paralysis and left foot drop, chronic nerve pain, peroneal nerve damage, numbness to right lower extremity, and weakness to both lower extremities.Two devices: serial numbers (b)(4), ref 3086 octrode sjm (01) 05414734401555(17) 210219 (21) 17965073 exp 02/19/2021; (01) 05414734401555 (17) 210213 (21) 17955918 exp 02/13/2021.Abbott rep name - (b)(6) present in operatory surgery room and in recovery room.

• Brand Name: ST JUDE MEDICAL ABBOTT NEUROSTIMULATOR TRIAL WITH LUMBAR BURST
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT MEDICAL
• MDR Report Key: 8949682
• MDR Text Key: 156329070
• Report Number: MW5089462
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2021
• Device Model Number: 3086
• Device Lot Number: (01)05414734401555
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 48 YR
• Patient Weight: 85