MAUDE Adverse Event Report: MEDTRONIC SURESCAN SPINAL CORD STIMULATOR

Model Number 97714

Device Problems Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574); Low Battery (2584)

Patient Problems Fall (1848); Headache (1880); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Numbness (2415); Electric Shock (2554)

Event Date 12/27/2013

Event Type  Injury  

Event Description

Reporter complaining that the electronic stimulation device placed in his back has damaged his nerves and given him an infection at the site from fluid build up.Device implanted by dr.(b)(6) in (b)(6), and has never worked correctly since implantation.Receiving shocks that were painful and the medtronic rep attempted to adjust the device; however, the shocks continued so the dr turned the device off.The battery life ran out too quickly.Receive jolts whenever he moved to quickly that went down his leg and up his spine.Also had migraines from the device.Dr had an attitude when he complained and turned the device off, said he could not remove it because he was going on vacation.His associate removed the device.Once the device was removed, the headaches stopped.Headaches were so bad that he thought he had meningitis.Has been told that he has nerve damage from the fluid build up and the wires in his spine.Now complains of numbness in legs and falling when trying to walk.Fell recently and has torn rotator cuff and the meniscus in his knees may also be torn.Lot numbers 2 lead kits (va0d0hg008 and va0d0hg007), lead wire (977a160), charging system (nku106862n), and pt programmer (nmh019498n).Ref # 3004209178-2016-18570, 3004209178-2016-18572.

• Brand Name: SURESCAN SPINAL CORD STIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6085084
• MDR Text Key: 59522517
• Report Number: MW5065852
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 97714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DIAZEPAM; GABAPENTIN; HYDROCODONE
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 54 YR