Device Events – Example Signal Alert Email Report

NOTE: This is an example of a typical Signal Alert Report showing the Adverse Events resulting from the search, which for this example is for Spinal-Cord Stimulators for the month of January 2018. The report below shows the first 5 of the 1,983 Adverse Events resulting from the search. Each Adverse Event has a Title and a preview of the report narrative. Click on the Title to view the report details or click on the CHART icon to view the related chart.

SEARCH: LGW - Stimulator, Spinal-Cord, Totally Implanted For Pain Relief, January 2018

IMPLANTABLE NEUROSTIMULATOR – Medtronic , 2018-01-23 , 7213450

INFORMATION WAS RECEIVED FROM A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT HOPED ANOTHER PRODUCT WORKED BETTER THAN THE MANUFACTURER’S SPINAL STIMULATORS BECAUSE THE PATIENT HAD FOUR IN 18 MONTHS AND IT DESTROYED THEIR SPINE.

Medtronic , 2018-01-19 , 7206038

INFORMATION WAS RECEIVED FROM A PROSPECTIVE PATIENT REGARDING A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAS THE INS AND THE IMPLANT DID NOT WORK FOR HER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

MEDTRONIC SPINAL CORD STIMULATOR – Medtronic , 2018-01-09 , 7178777

…NEEDED SURGERY TO CHANGE LOCATION OF BATTERY. LATER IN THE YEAR THE WIRES ALMOST CAME THROUGH MY SKIN REQUIRING ANOTHER SURGERY TO HAVE THEM PULL BACK IN FURTHER. TO THIS DAY THE WIRES GOING UP MY BACK CAUSE MODERATE PAIN 24/7. THIS IS WITH THE MEDTRONIC SPINAL CORD STIMULATOR . SPINAL CORD STIMULATOR IMPLANT DOESN’T WORK TO CONTROL PAIN LIKE THE TRIAL DID, NOT EVEN CLOSE.

ALGOVITA SPINAL CORD STIMULATION – Nuvectra Corporation , 2018-01-04 , 7165545

IT WAS REPORTED TO NUVECTRA THAT A REVISION WAS PERFORMED TO RE-POSITION THE STIMULATOR TO PROVIDE IMPROVED BATTERY RECHARGE. SUBSEQUENTLY, DURING SURGERY, THE STIMULATOR WAS REPLACED DUE TO BATTERY DRAINAGE. THE STIMULATOR BATTERY WAS NOT CHARGED PRIOR TO THE REVISION SURGERY. THE PATIENT IS DOING WELL.

IMPLANTABLE NEUROSTIMULATOR – Medtronic , 2018-01-02 , 7157376

CONCOMITANT PRODUCT(S): PRODUCT ID: NEU_INS_ STIMULATOR , LOT# SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.