MAUDE Adverse Event Report: ABBOTT ABBOTT INS AND ADAPTOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Device Problems Overheating of Device (1437); Output Problem (3005)

Patient Problems Pain (1994); Burning Sensation (2146); Electric Shock (2554)

Event Type  Injury  

Event Description

Patient had their first medtronic ins replaced with an abbott ins (and adaptor) sometime between 2014 and 2017.Around (b)(6) 2021/(b)(6) 2022, the pt was having heating/burning/shocking sensations and pain at the site of the lead and a return of back pain.On (b)(6) 2022, the abbott ins was replaced with a medtronic ins.During that ins replacement surgery, it was discovered that the medtronic paddle lead that had been implanted with the medtronic ins in 2014, had a completely severed cable.The hcp and the rep believe the paddle lead was severed during the ins replacement surgery when the abbott ins was put in.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ABBOTT INS AND ADAPTOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 17529701
• MDR Text Key: 321040504
• Report Number: MW5136625
• Device Sequence Number: 1
• Product Code: LGW
• 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: 04/08/2022

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