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

Model Number NEU_INS_STIMULATOR

Device Problems Therapy Delivered to Incorrect Body Area (1508); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Undesired Nerve Stimulation (1980); Pain (1994); Seroma (2069); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for a back problem.It was reported that the there was a malfunctioning internal pain controlling device and there were problems.The patient has had +- 4 back operations the last 5 months, all done by the same doctor.From day 1 that they fitted the new battery to help the patient with their pain, they have had problems with it.First, it did not stimulate the correct places as required by the patient and as it was before.Second, the battery did not charge full from day 1.There were complications: constant back pain and left side constantly burning in lower back and left leg, constant pain in right side top leg.That the battery does not want to charge the way it's supposed to.It was recommended to have the doctor remove some of the liquid swelling by a needle.There was persistent pain in their bladder and kidney so the patient had to switch the ins off to stop the pain from last operation.The doctor thought it was the battery but the patient was constantly under pain.The second last operation in december, the patient started to feel the pain a day before they left the hospital.The ins was not working correctly.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11446335
• MDR Text Key: 239365366
• Report Number: 2182207-2021-00406
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• 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
• Date Manufacturer Received: 03/04/2021
• 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
• Patient Outcome(s): Required Intervention