IMPLANTABLE NEUROSTIMULATOR

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT STATES WHEN THEY INSTALLED THE INS HAD PROBLEMS RIGHT AWAY. PT STATES HAVING A LOT OF PAIN AROUND THE INS AND ITS NOTHING LIKE SHE EVER HAD BEFORE. PT STATES HASN'T WORKED SINCE 2012.  PT STATES PROBLEM AT BATTERY SITE. PT STATES PAIN IN THE PAST MONTH, A REVISION WAS DONE AFTER BATTERY WAS PUT IN BECAUSE BATTERY WASN'T WORKING. PT STATES WHEN FIRST INSTALLED INS GOT HOT WOULDN'T HOLD A CHARGE AND WOULD GET HOT WHEN CHARGING. PT STATES SHE WAS GOING TO HCP EVERY OTHER DAY AND WASN'T SURE WHAT WAS GOING ON AND FINALLY THE INS JUST DIED. PT STATES DEVICE HAS BEEN OFF SINCE 2012 AND PT STATES SHE WANTS THIS REMOVED COMPLETELY. PT STATES TYLENOL DOESN'T EVEN HELP WITH THE PAIN AND IT DOES FEEL WARM AROUND THE SITE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

Additional Manufacturer Narrative

MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

Description of Event or Problem

ADDITIONAL INFORMATION FROM THE HCP INDICATED THAT THE PATIENT HAS NOT HAD THEIR DEVICE TURNED ON SINCE 2012. THEY REDIRECTED THE PATIENT TO THEIR PRIMARY HCP IN FLORIDA.