MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN EXTERNAL NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_ENS_STIMULATOR

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

Patient Problems Pain (1994); Scarring (2061); Complaint, Ill-Defined (2331); Injury (2348)

Event Date 02/26/2015

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 977d260, serial# (b)(4), product type: screening device.Product id: 977d260, serial# (b)(4), product type: screening device.

Event Description

The patient alleged that they were "battered" by a manufacturer representative and doctor which led to serious injuries, hundreds of thousands of dollars in medical expenses, lost income in the past and future of (b)(6), severe unfixable scarring, permanent disfigurement, lost time, diminished earning capacity, and other harms and losses.The patient also alleged that they were defrauded about the trial implant of a neurostimulator as they were supposedly told that there were "no risks because you can try it before you buy it" and was told other intentional misrepresentations about the implant of the neurostimulator.The patient alleged that they were not advised of all of the risks, such as bodily harm, infection, or other possible bad outcomes of the medical procedure and never gave oral or written consent for the procedure.Allegedly, the material risks of the procedure were not disclosed or were concealed.The patient alleged that these issues were concealed or not disclosed with the intent of creating a false impression of the actual facts, specifically that the proposed procedure was completely safe without any risks of complication.The patient alleged that they acted in reliance upon the material misrepresentations and nondisclosure and concealment of the facts.It was alleged that a written consent document was forged by an unknown individual to give the impression that the patient was fully advised of all the risks of the procedure.Allegedly, due to these issues the patient had physical and mental pain and suffering and they were also physically impaired after they underwent the trial procedure.

• Brand Name: UNKNOWN EXTERNAL NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5519684
• MDR Text Key: 40960528
• Report Number: 3007566237-2016-01455
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2016
• 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
• Patient Outcome(s): Other