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

Model Number NEU_INS_STIMULATOR

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problem Pain (1994)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that at the end of (b)(6) (2017) they had a spinal fusion and now, when they turned their stimulator on they couldn¿t seem to control it; they stated that it was set on something that was working just fine, but if they wanted to go down some they could not do that.Clarification revealed that the patient was trying to use their patient programmer and it showed zeros where they used to see numbers.The patient stated that they were successfully recharging their ins at the beginning of the call and the implant battery showed nearly full.The patient stated the numbers were normally at 3, 4, 5 or 4.5 and that they were all zeros now.They state that was their problem now, because they knew it was not at zero because they were feeling stimulation.The patient stated that they did not use their antenna because the implant was in their abdomen, but they could not see the screen when they placed it against their implant.The patient was encouraged to try using the antenna.The patient found the antenna and patient services worked with the patient to use their patient programmer.The patient was successful at syncing and brought up their settings.The patient stated that they were on group a, and the bottom row on the patient programmer showed the program number was one and zero.The patient navigated to program two and saw the voltage was 4.5.The patient was successfully able to decrease stimulation on program 2.The patient navigated back to program 1 and was successful to increase the number to 0.10.Patient services asked if the patient had turned their stimulation down to zero and off in order to have the surgery in august and the patient stated no.They said their healthcare provider (hcp) told them the surgery was a struggle trying to do the fusion, working around the wires, but the patient stated that after the fusion they noticed that they were getting more stimulation on their right side than they ever did.They stated that it was in the right place, and it was a good thing because they had pain there.The patient stated that they were happy with the way stimulation was right this moment.It was reported the patient programmer was functioning as expected.It was reported the event occurred on (b)(6) 2017.No further complications were reported/anticipated.

• 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 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7097056
• MDR Text Key: 95081123
• Report Number: 3007566237-2017-05096
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/07/2017
• 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 Age: 70 YR