ACTIVA
Report
- Report Number
- 3007566237-2019-00016
- Event Type
- Injury
- Date Received
- January 3, 2019
- Report Date
- February 15, 2019
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 00613994761057
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
PRODUCT ID 37602 LOT# SERIAL# (B)(4),IMPLANTED: (B)(6) 2012, EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIM ULATOR PRODUCT ID 3387S-40 LOT# V137747 SERIAL# , IMPLANTED: (B)(6) 2009,EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V067713 SERIAL# IMPLANTED: (B)(6) 2008,EXPLANTED: PRODUCT TYPE LEAD. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REITERATING THAT THEY COULDN'T CONNECT WITH THE 8840. THE INS WAS TURNED OFF FOR A CARDIAC PROCEDURE. THE PATIENT IS CONNECTED TO MANY ELECTROCARDIOGRAMS (EKG) MONITORING EQUIPMENT. THEY INDICATED THEY WOULD TURN THE INS OFF WITH A PROGRAMMER. THE REP ALSO REPORTED THE CAUSE OF THE LEAD PROTRUDING OUT WAS NOT DETERMINE. THEY ARE UNSURE WHEN IT STARTED. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED. UNKNOWN IF THE ISSUE IS RESOLVED. THIS INFO WAS CONFIRMED BY THE PHYSICIAN.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP STATING THE DEVICE WAS SCHEDULED FOR EXPLANT ON (B)(6) 2018.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP INDICATING THE CAUSE OF THE LEAD PROTRUSION WAS DUE TO WOUND BREAKDOWN AND POOR SELF CARE. IT WAS UNKNOWN WHEN THE EVENT FIRST OCCURRED. THE ISSUE HAS BEEN RESOLVED. NO FURTHER COMPLICATIONS WERE ANTICIPATED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT #: (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT #: (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 26-MAR-2011, UDI#: (B)(4). PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 11-SEP-2010, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE TREATMENT OF PARKINSON¿S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT HAD A CRANIAL INFECTION AND THEY WERE GOING TO DO A LEAD EXPLANT. IT WAS REPORTED THE LEAD WAS PROTRUDING OUT. THE REP WAS UNSURE IF ONE OR BOTH OF THE LEADS WERE EXPLANTED. BOTH SYSTEMS HAD BEEN OFF FOR AT LEAST A YEAR. THE REP WAS UNABLE TO COMMUNICATE WITH EITHER INS WITH THE 8840 CLINICIAN PROGRAMMER. NO FURTHER INFORMATION WAS PROVIDED AS THE HEALTH CARE PROFESSIONAL (HCP) WAS READY TO BEGIN SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5028 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | 37602 | 00613994761057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |