SURESCAN
Report
- Report Number
- 3004209178-2019-21488
- Event Type
- Malfunction
- Date Received
- November 11, 2019
- Report Date
- November 10, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109513
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF D10: PRODUCT ID 3987A LOT# N072813 SERIAL#, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD PRODUCT ID 3987A LOT# N072813 , IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. 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.
THE REASON FOR CALL WAS CALLER STATED THAT WHILE INTERROGATING INS WITH TABLET, PROGRESS BAR GETS TO AROUND 90% AND PATIENT FEELS SHOCKING SENSATION. CALLER STATED PATIENT IS IMPLANTED WITH PERIPHERAL NERVE STIM FOR ARM. PATIENT HAD EPIDURAL INJECTION AND PROPOFOL TODAY SO THEY WE'RE "OUT OF IT" FOR A LITTLE WHILE AND THEREFORE, CALLER WAS ABLE TO INTERROGATE INS DURING THAT TIME TO AVOID PATIENT FEELING SHOCKING. CALLER STATED THIS HAS HAPPENED AT THE LAST 2 APPOINTMENTS AND SPECIFICALLY HAD A NOTE FROM MDT REP ON (B)(6) 2023 THAT PATIENT DIDN'T WANT INS INTERROGATED DUE TO SHOCKING BUT THAT THERAPY WAS WORKING WELL AND PATIENT DIDN'T WANT ANY CHANGES. CALLER STATED TODAY IMPEDANCES WERE ALL NORMAL AND THERAPY CONTINUES TO WORK FOR THE PATIENT. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. TSS REVIEWED THAT SHOCKING WOULDN'T BE EXPECTED DURING INTERROGATION BUT IT DOES REQUIRE ENERGY AND CAN AFFECT PATIENTS DIFFERENTLY, ESPECIALLY IF IMPLANTED FOR PNS.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3987A, LOT#: N072813, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3987A, LOT#: N072813, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3987A, SERIAL/LOT #: (B)(4), UBD: 05-JUN-2010, UDI#: (B)(4). PRODUCT ID: 3987A, SERIAL/LOT #: (B)(4), UBD: 05-JUN-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3987A, LOT#: N072813, IMPLANTED: (B)(6) 2007: PRODUCT TYPE: LEAD. PRODUCT ID: 3987A, LOT# :N072813, IMPLANTED: (B)(6) 2007: PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN AND RSD/CAUSALGIA ¿ COMPLEX REGIONAL PAIN SYNDROME. THE REP REPORTED THAT THE PATIENT HAD A PNS SYSTEM, TWO QUAD LEADS IN THE ELBOW TO STIMULATE THE ULNAR NERVE. THE REP USED THE THERAPY APPLICATION TO START AN INTERROGATION AND AT ABOUT 80% COMPLETION OF THE INTERROGATION, THE PATIENT JOLTED HER ARM AND SCREAMED. THE REP STOPPED THE COMMUNICATION ATTEMPT BY REMOVING THE COMMUNICATOR FROM OVER THE INS. THE PATIENT WAS RELUCTANT TO HAVE THE COMMUNICATOR USED AGAIN TO ATTEMPT AN INTERROGATION, SO THE REP USED THE CLINICIAN PROGRAMMER AND THERE WAS NO JOLTING RESPONSE. THE REP REPORTED THAT THE PATIENT¿S DOG JUMPED ON HER AND THE PATIENT THOUGHT THAT MAY HAVE KNOCKED ONE OF THE LEADS LOOSE. THE REP RAN IMPEDANCES AND THE PATIENT EXPERIENCED A SIMILAR JOLTING SENSATION DURING THE IMPEDANCE TEST. THE REP WASN¿T ABLE TO COMPLETE AN IMPEDANCE TEST. THE REP REPORTED THAT STIMULATION WAS OFF WHEN THE SYSTEM WAS INTERROGATED. THE PATIENT REPORTED 100% STIMULATION USAGE AND EXPECTED STIMULATION TO BE ON, BUT THE CLINICIAN PROGRAMMER SHOWED 57% USAGE. IT WAS NOTED THAT IT WASN¿T CLEAR WHY THE PATIENT THOUGHT THE DOG JUMPING ON HER MAY HAVE BEEN A PROBLEM FOR THE IMPLANTED SYSTEM. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE JOLTING AND LEADS BEING KNOCKED LOOSE. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1100627 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97702 | 00643169109513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |