SURESCAN
Report
- Report Number
- 3004209178-2017-23180
- Event Type
- Injury
- Date Received
- November 6, 2017
- Date of Event
- October 31, 2017
- Report Date
- March 20, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169109483
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
SUPPLEMENTAL TO UPDATE APPLY TO (B)(4) APPLY TO (B)(4) AND (B)(4) ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (B)(4) FOUND NO ANOMALIES. ANALYSIS OF THE ELECTRICAL LEADS (B)(4) AND (B)(4) FOUND THAT THE LEAD CONDUCTOR BODY WAS BROKEN WITHIN 10CM OF THE CONNECTOR AREA. PRODUCT ID 377775 LOT# V013204 IMPLANTED: (B)(6)2007 EXPLANTED: (B)(6)2017 PRODUCT TYPE LEAD PRODUCT ID 377775 LOT# V004485 IMPLANTED: (B)(6)2007 EXPLANTED: (B)(6)2017 PRODUCT TYPE LEAD INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 377775, (B)(4), UBD: 2010-OCT-04, (B)(4); PRODUCT ID: 377775, (B)(4), UBD: 2010-MAR-08, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT RETURNED BY REP. NO ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE HIGH IMPEDANCES, THERAPY TURNING OFF BY ITSELF AND BATTERY DRAINING UNEXPECTEDLY WAS UNKNOWN. THE REP REPORTED THAT THEY REPROGRAMMED THE PATIENT WITHOUT USING QUESTIONABLE ELECTRODES AND GOT FULL COVERAGE OF PAINFUL AREAS. THE REP REPORTED THAT THEY REEDUCATED THE PATIENT ON PROPER USE OF RECHARGER AND IMPORTANCE OF NOT HITTING THE OFF BUTTON INADVERTENTLY. THE REP REPORTED THAT THEY ASKED THE PATIENT TO NOTIFY THEM IF THE ISSUES CONTINUED AND THE PATIENT HAD NOT REACHED OUT SINCE. THE REP REPORTED THAT THE PATIENT WAS OVERWEIGHT. NO FURTHER COMPLICATIONS WERE REPORTED.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT WAS SCHEDULED FOR IMPLANT REPLACEMENT ON (B)(6)2017.
INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. THE REP REPORTED THAT ELECTRODES 1, 2, 3, 9, 10, AND 15 WERE SHOWING GREATER THAN 10,000 OHMS. THE REP REPORTED THAT THEY RAN IMPEDANCES AT 3V AND SOME OF THOSE VALUES CAME DOWN AND SOME CAME UP. THE REP ALSO REPORTED THAT THE PATIENT¿S THERAPY WAS TURNING OFF BY ITSELF. THE REP REPORTED THAT ON (B)(6) 2017 AND (B)(6) 2017 THE THERAPY TURNED OFF BY ITSELF AND IT WAS VERIFIED WITH THE PATIENT PROGRAMMER. THE REP ALSO REPORTED THAT THE PATIENT WAS AT 100% ON (B)(6) 2017 AFTER RECHARGING AND WHEN HE TURNED STIMULATION BACK ON, ON (B)(6) 2017 HE WAS AT 50%. THE REP REPORTED THAT THEY REPROGRAMMED THE PATIENT WITH FULL COVERAGE OF LEFT THORACIC CHEST USING ELECTRODES 1 AND 3 AND RIGHT THORACIC USING ELECTRODES 9 AND 10. THE REP REPORTED THAT THE PATIENT HAD INSTANT PAIN RELIEF AND WAS VERY HAPPY. THE REP REPORTED THAT THEY EDUCATED THE PATIENT ON DIFFERENT RECHARGING SCREENS AS DISCUSSED AND THEY WOULD TAKE IT FROM THERE. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 783427 | SURESCAN | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97714 | 00643169109483 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |