MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. PRESTIGE LP; PROSTHESIS, INTERVERTEBRAL DISC

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/07/2017

Event Type  Injury  

Event Description

Caller was implanted with a prestige lp device on (b)(6) 2017 since then she has been in pain.She said she was told after implantation that the device was not medically necessary because it is indicated for patient with myelopathy or cervical myelopathy and was not suffering from any of these disease.She said that she did not know about the implanted device until she read the surgical report.She stated she was never diagnosed with any of these disease by a doctor and not in her medical history.She believed the doctor is an insurance scam because at follow up the doctor asked if the pain in her arm subsided and she replied that she has no pain with her arm.She sought for a second opinion and was referred to a another doctor by her family doctor.The prestige device was explanted in (b)(6) 2018 by this new doctor who stated that it was wrong to do the procedure in the first place.She said even though the device has been explanted severe damaged had been done to her neck.

• Brand Name: PRESTIGE LP
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 13534907
• MDR Text Key: 285672070
• Report Number: MW5107437
• Device Sequence Number: 1
• Product Code: MJO
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White