MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG LEAD

Model Number MN10450-50A

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

Patient Problems Headache (1880); Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Numbness (2415); Weight Changes (2607)

Event Date 03/14/2022

Event Type  Injury  

Event Description

User facility medwatch (reference mw5149571) received that states ¿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.¿ note: issue reported for the trial implant is reported under related manufacturer reference number: (b)(4) and issue related to lead fracture is reported under: (b)(4).

Manufacturer Narrative

Date of event is estimated.Additional components potentially involved in the event include: common device name: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 8048634.

Manufacturer Narrative

Investigation was unable to determine which of the leads attributed to the issue: additional components potentially involved in the event include: common device name: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 8048634.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 18656161
• MDR Text Key: 334725441
• Report Number: 1627487-2024-00612
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Model Number: MN10450-50A
• Device Lot Number: 8048634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRG IPG; DRG LEAD
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 91 KG