SURESCAN
Report
- Report Number
- 2182207-2024-00126
- Event Type
- Injury
- Date Received
- January 10, 2024
- Date of Event
- December 18, 2023
- Report Date
- December 2, 2024
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 00643169109490
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF D10: PRODUCT ID: 377775, SERIAL#: (B)(6), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377745, LOT# V010634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377745, LOT# V010660, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: LOT# V012045, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 97713, SERIAL#: (B)(6), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 97713 LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 377745 LOT# V010634, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD PRODUCT ID: 377745 LOT# V010660, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD PRODUCT ID: 377760 LOT# V012045, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377775, SERIAL/LOT #: (B)(6). PRODUCT ID: 377745, SERIAL/LOT #: (B)(6), UBD: 09-AUG-2010, UDI#: (B)(4). PRODUCT ID: 377745, SERIAL/LOT #: (B)(6), UBD: 10-AUG-2010, UDI#: (B)(4). PRODUCT ID: 377760, SERIAL/LOT #: (B)(6), UBD: 08-SEP-2010, UDI#: (B)(4). PATIENT HAS 2 INS. IT WAS UNKNOWN WHICH INS WAS AT FAULT THEREFORE 2 REGULATORY SYSTEM REPORTS WERE SUBMITTED. PLEASE SEE RR# 800149705 FOR THE OTHER INS. 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.
CONTINUATION OF D10: PRODUCT ID 377775 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD, PRODUCT ID 377745, LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD, PRODUCT ID 377745, LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2007,PRODUCT TYPE LEAD, PRODUCT ID 377760, LOT# SERIAL#(B)(6) , IMPLANTED: 2007, PRODUCT TYPE LEAD PRODUCT ID 97713, LOT# SERIAL# (B)(6), IMPLANTED: (B)(6) 2015, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 97713 LOT# SERIAL# (B)(6) , IMPLANTED: (B)(6) 2015, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 377745 LOT# SERIAL# (B)(6) , IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD, PRODUCT ID 377745 LOT# SERIAL#(B)(6) , IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD, PRODUCT ID 377760, LOT# SERIAL# (B)(6) , IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THEIR WAS A LEAD ISSUE; HIGH IMPEDANCE 10K. PATIENT HAS 2 GENERATORS AND REACHING THEIR END OF SERVICE. PLAN TO REPLACE WAS UNDER WAY. IN THE PROCESS OF PREPARING FOR REPLACEMENT, IMPEDANCES WERE CHECKED. THE ELECTRODES 8-15 WERE OUT OF RANGE. PATIENT BEING REFERRED TO NEUROSURGEON FOR LEAD REVISION.
INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS THAT THEY WANTED TO KNOW IF THEIR TWO RESTORE NEUROSTIMULATORS WERE COMPATIBLE WITH A TMS (TRANSCRANIAL MAGNETIC STIMULATION) THERAPY PROCEDURE. PATIENT SAID THAT THEY DIDN'T KNOW IF THE DEVICES STILL WORKED, AS THEY HADN'T TURNED THEM ON ANYMORE AND THEIR QUALITY OF LIFE WAS ABOUT THE SAME. YET, THEY NOTED THAT THE DEVICES WERE DUE TO BE REPLACED AND THAT WAS SOMETHING THEY COULD NOT PHYSICALLY HANDLE RIGHT NOW. PATIENT STATED THAT WHEN THEY LAST HAD THE DEVICES INTERROGATED, THEY WERE TOLD THAT THEY WERE GOING TO NEED TO LIKELY HAVE THE LEADS REPLACED AS WELL SINCE THEY WERE TOLD THAT THE WIRES WERE GOING BAD. PATIENT STATED THAT ON THE RIGHT SIDE, ONE OF THE LEAD WIRES WAS DEAD AND BROKEN AND NEEDED TO BE REPLACED. PATIENT SHARED THERE WERE IMPEDANCES ON THE LEADS. AGENT UNDERSTOOD THAT SINCE THE PATIENT HAD ISSUES WITH THE LEADS, THEY DIDN'T USE THE SCS DEVICES. PATIENT MENTIONED THAT THEY KNEW A LOT LESS ABOUT THE ORIGIN OF THEIR PAIN WHEN THEY WERE IMPLANTED IN 2006, SO THEY WERE NOW GOING THROUGH ALL OF THAT AGAIN. AGENT CONSULTED WITH TECHNICAL SERVICES AND REVIEWED INFORMATION WITH THE PATIENT. AGENT PROVIDED THE OFFICE OF MEDICAL AFFAIRS PHONE NUMBER FOR THEIR DOCTOR TO CALL. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT SENT AN EMAIL TO THE PATIENT REVIEWING WHAT WAS TALKED ABOUT ON THE CALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1032950 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC NEUROMODULATION | 97713 | 00643169109490 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention | "SEE H10...."| "SEE H11...." |