PERCEPT
Report
- Report Number
- 3004209178-2022-05876
- Event Type
- Malfunction
- Date Received
- May 9, 2022
- Report Date
- June 6, 2022
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00763000519216
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3708660, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37601, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 16-NOV-2020, UDI#: (B)(4); PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 28-NOV-2020, UDI#: (B)(4). REFER TO MANUFACTURING REPORT #3004209178-2022-01426 FOR RELATED SYSTEM. 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.
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.
CONTINUATION OF D10: PRODUCT ID: 3708660, SERIAL# (B)(6), PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708660, SERIAL# (B)(6), PRODUCT TYPE: EXTENSION; PRODUCT ID: 37601, SERIAL# (B)(6), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.
CONTINUATION OF D10: PRODUCT ID: 3708660, SERIAL# (B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(6), PRODUCT TYPE: EXTENSION. PRODUCT ID: 37601, SERIAL# (B)(6), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.
IT WAS REPORTED THAT PATIENT HAS HIGH IMPEDANCES: 8 4400 OHMS9 510010 599011 53608<(>&<)>11 27709<(>&<)>11 289610<(>&<)>11 23098<(>&<)>10 25329<(>&<)>10 21738<(>&<)>9 1488 OHMS. THE PROVIDER PROGRAMMED BIPOLAR AND SHE WAS ABLE TO GET THERAPY IMPEDANCE. LEFT 1-2+ 2393 OHMS, 0.9 MA, RIGHT. 11-10+ 0.6 MA 2738 OHMS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE AND CONFIRMED BY THE PROVIDER. IT WAS UNKNOWN IF PATIENT IS STILL RECEIVING THERAPEUTIC BENEFIT. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY HAD THEIR NEUROSTIMULATOR AND EXTENSIONS REPLACED TODAY. THE CURRENT IMPEDANCE SITUATION WAS: MONOPOLARS PRIOR TO REPLACEMENT WERE C/0 4600 C/1 6000 C/2 5600 C/3 6800 C/8 8200 C/9 6100 C/10 7270 C/11 7600 WITH BIPOLARS ¿BASICALLY HALF¿ OF MONOPLARS. AFTER REPLACEMENT THE LEFT SIDE SHOWED ALL MONOPOLARS WERE GREATER THAN 5,000 OHMS AND ALL BIPOLARS WERE ¿GREEN¿ WITH A RANGE OF 2,500-3,900 OHMS. THE RIGHT SIDE SHOWED MONOPOLARS GREATER THAN 5,000 OHMS AND BIPOLARS WERE 4,200-6,200 OHMS. THE PATIENT WAS PREVIOUSLY PROGRAMMED ON 11-10+ WHICH SHOWED 4,235 OHMS. PROGRAMMING ON 11/10 WAS REVIEWED WHICH MAY BE DIFFICULT GIVEN IMPEDANCES TO GET QUALITY THERAPY.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED FOLLOWING NEUROSTIMULATOR AND EXTENSION REPLACEMENT ON MAY 5TH THE HIGH IMPEDANCES ON MONOPOLAR AND BIPOLAR DIDN¿T RESOLVE. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY ON THE LEFT SIDE PRIOR TO SURGERY AND WAS RECEIVING THERAPY POST-SURGERY. ON THE RIGHT SIDE THE PATIENT WASN¿T RECEIVING THERAPY DUE TO HIGH IMPEDANCES, AND POST REPLACEMENT THE PATIENT WASN¿T RECEIVING THERAPY ON THE RIGHT SIDE. . THE REP NOTED THE CAUSE OF THE HIGH IMPEDANCES WASN¿T DETERMINED AND THE DEVICES WERE WAITING TO BE RELEASED FROM THE HOSPITAL FOR FURTHER EVALUATION.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE REP CALLED TO DISCUSS IMPEDANCE READINGS THAT ARE NOT AS EXPECTED BECAUSE THE UNIPOLARS WERE DOUBLE OF WHAT THE BIPOLARS ARE WHICH IS TYPICALLY THE OPPOSITE. THE PATIENT WAS SEEN IN (B)(6) 2022 WHERE THESE IMPEDANCES WERE SEEN. DUE TO THESE IMPEDANCES, HCP NEEDED TO CHANGE PROGRAMMING TO BIPOLAR SETTINGS DUE TO THESE IMPEDANCES. PATIENT HAD SURGERY TO REMOVE OLD INS AND OLD EXTENSIONS WITH THE HOPE THAT WOULD RESOLVE THE ISSUE BUT IT DIDN'T. REP DID SEE WORSENING OF IMPEDANCE VALUES WITH THE ACTIVA PC PRIOR TO SURGERY COMPARED TO (B)(6) 2022 MEASUREMENTS. REP INDICATED THAT THE IMPEDANCES STAYED VERY SIMILAR ONCE THE NEW EXTENSIONS/INS WERE IMPLANTED. THE LEADS WERE NOT TESTED DUE TO CONCERN ABOUT DAMAGE WHEN INSERTING STYLET AND TWIST CABLE. THE PATIENT ISN'T A CANDIDATE FOR REPLACING LEADS DUE TO CURRENT HEALTH STATUS AND AGE.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP) WHO REPORTED THAT IT WAS UNKNOWN IF FURTHER ACTIONS WERE PLANNED TO RESOLVE THE HIGH IMPEDANCES OR IF FURTHER PROGRAMMING WAS DONE TO RESOLVE THE LACK OF THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1552738 | PERCEPT | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | B35200 | 00763000519216 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |