SURESCAN
Report
- Report Number
- 2182207-2024-04409
- Event Type
- Injury
- Date Received
- October 29, 2024
- Report Date
- July 28, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169613645
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID 977A260, LOT# SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2024, 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.
CONTINUATION OF D10: PRODUCT ID 977A260 SERIAL# UNKNOWN IMPLANTED: (B)(6)2016 EXPLANTED: (B)(6)2024 PRODUCT TYPE LEAD H2: CORRECTION. THE PREVIOUS REPORT LISTED THE OUTCOME ATTRIBUTED TO THE ADVERSE EVENT AS "OTHER" DUE TO THE REPORT OF ANGINA. IT WAS CLARIFIED THAT THE PATIENT'S DEVICE/THERAPY DID NOT CAUSE CHEST PAIN AND THEY WERE ORIGINALLY IMPLANTED FOR REFRACTORY ANGINA. THEREFORE, THE PATIENT'S DEVICE/THERAPY DID NOT CAUSE ANGINA TO OCCUR, AND THE PREVIOUSLY DOCUMENTED IME/ANNEX E OF E061201 NO LONGER APPLIES. 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.
CONTINUATION OF D10: PRODUCT ID 977A260, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2016, EXPLANTED: (B)(6) 2024, PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: UNKNOWN, E1 PHONE NUMBER: (B)(6), H6 CODES BELONG TO THE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CONTINUATION OF D10: PRODUCT ID 977A260 SERIAL# UNKNOWN IMPLANTED: (B)(6) 2016 EXPLANTED: (B)(6) 2024 PRODUCT TYPE LEAD H3: THE LEAD, MODEL# 977A260 SERIAL# UNKNOWN, WAS RETURNED FOR PRODUCT ANALYSIS. ANALYSIS OF THE LEAD REVEALED NO SIGNIFICANT ANOMALY. THE RETURNED LEAD WAS ATTACHED TO A KNOWN, GOOD WIRELESS EXTERNAL NEUROSTIMULATOR AND IMPEDANCES WERE MEASURED. NORMAL IMPEDANCES WERE OBSERVED. THERE WERE NO SHORTS BETWEEN CIRCUITS AND THE CONTINUITY WAS ACCEPTABLE. THERE WAS DEGRADED INSULATION (METAL ION OXIDATION). THERE WERE IMPRESSIONS IN THE OUTER INSULATION NEAR THE NUMBER 7 CONNECTOR. CONNECTOR NUMBER 0 WAS CRUSHED. THERE WERE SUSPECTED ABRASIONS EXPOSING THE BRAID, 14.4 CM FROM THE DISTAL END. ANALYSIS IDENTIFIED THAT THE OUTER INSULATION WAS MELTED IN THE BODY OF THE LEAD, WHICH WAS CONSISTENT WITH ELECTROCAUTERY USE IN THE PROXIMITY OF THE 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.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE. THE REPRESENTATIVE CLARIFIED THAT WHEN IT WAS REPORTED THAT THE PATIENT'S INS WAS REPLACED EARLY, THIS WAS DUE TO THE APPROACHING ERI. THE REPRESENTATIVE NOTED THAT THEY RETURNED THE LEAD, BUT FEDEX WAS UNABLE TO PROVIDE A TRACKING NUMBER AS THEY SENT THE PACKAGE BACK SO MANY MONTHS AGO.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE. THE REPRESENTATIVE CLARIFIED THE REPORTED EVENT. THE PATIENT'S DEVICE/THERAPY DID NOT CAUSE CHEST PAIN AND THE PATIENT WAS ORIGINALLY IMPLANTED FOR REFRACTORY ANGINA. THE PATIENT RECEIVED GOOD THERAPY FROM THEIR INS FOR THEIR ANGINA SYMPTOMS INITIALLY. THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT IN (B)(6)2017. IT WAS NOTED THAT IMPEDANCES WERE OK AFTER THAT AND ALL WAS WELL AT A THERAPY CHECK IN (B)(6)2018. ON (B)(6)2023, THE PATIENT VISITED THE CLINIC DUE TO THEM EXPERIENCING ZAPPING AND A LOSS OF OPTIMAL THERAPY; CONTACTS 8, 9, 10, AND 11 WERE OVER 10,000 OHMS. THE ZAPPING AND SUBOPTIMAL THERAPY HAD BEEN OCCURRING FOR A WHILE, BUT THE PATIENT WAS NOT SEEN IN THE CLINIC RIGHT AT THE ONSET; IT WAS NOTED THAT VARIOUS FACTORS WERE INVOLVED. THE PATIENT WAS REPROGRAMMED TO OPTIMIZE THEIR THERAPY ON (B)(6)2024, BUT THEY WERE UNABLE TO RECEIVE GOOD COVERAGE WITHOUT USING THE AFFECTED CONTACTS. THE PATIENT'S FRACTURED LEAD WAS REPLACED AND THE PATIENT'S INS WAS REPLACED "EARLY" ON (B)(6)2024 (IT WAS NOTED THAT THE PATIENT'S INS WAS EXPECTED TO REACH ERI IN (B)(6) 2025). IMPEDANCES NORMALIZED SINCE THE SYSTEM REVISION, AND THEY WERE STILL WORKING ON OPTIMIZING THE PATIENT'S THERAPY/COVERAGE.
INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT AT THE CLINIC VISIT ON (B)(6) 2023, THE PATIENT HAD LOSS OF OPTIMAL THERAPY INCLUDING ZAPPING. ¿ANGINA¿ PATIENT NOTED. CONTACTS 8-11 WERE >10,000 OHMS AT 0.7V. NO KNOWN OCCURRENCE TO CAUSE THE ZAPPING OR IMPEDANCES. ONE OF THE TWO LEADS WAS REPLACED ON (B)(6) 2024, DUE TO THE 4 CONTACTS HAVING IMPEDANCES OF >10,000 OHMS. IT WAS UNKNOWN IF THE LEAD REPLACED WAS MODEL 977A260, SERIAL # (B)(6). PATIENT WAS ALIVE WITH NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 928948 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97713 | 00643169613645 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R | "SEE H11....". |