ACTIVA
Report
- Report Number
- 3004209178-2019-23534
- Event Type
- Injury
- Date Received
- December 10, 2019
- Date of Event
- December 3, 2019
- Report Date
- February 24, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169864191
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
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.
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT IMPEDANCES WERE DOCUMENTED AND PATIENT HAD THE ABILITY TO TURN DOWN AMPLITUDE TO LOWER 0.7. CONTACT 3 WAS MISSING FROM THE LEAD. IT'S MISSING AND THE LEAD IS STILL IN THE BRAIN AND CONNECTED TO A NEW EXTENSION AND INS. THE CAUSE OF THE END OF SERVICE WAS UNKNOWN. UNKNOWN IF THE BATTERY DEPLETED EARLY OR NORMAL. HOWEVER, C AND 3 HAD HIGH IMPEDANCE IN PRE-OP. THE EXPLANTED INS AND EXTENSIONS WERE DISCARDED. THE REP MET WITH THE PATIENT AT THE DOCTOR'S OFFICE AND CREATED A NEW GROUP WITH DIFFERENT SETTINGS. GROUP C. PATIENT IS GOING TO DECIDE LATER IF HE WANTS TO HAVE THE LEAD REPLACEMENT SURGERY. THEY DO NOT HAVE A FOLLOW-UP DATE.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40; LOT#: V142617, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: V130906, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 18-APR-2011, UDI#: (B)(4); PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 26-MAR-2011, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID: 3387S-40, LOT# V142617, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, LOT# V130906, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD; PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3708640, SERIAL# (B)(4), IMPLANTED: (B)(6) 2019, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION; PRODUCT ID: 37601, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.
INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND DEEP BRAIN STIMULATION (DBS) THERAPY INDICATIONS. IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES IN BOTH PRE-OP AND POST-OP. THE IPG WAS INTERROGATED BOTH TIMES. THE SESSION REPORT FOR POST-OP REPORTED THE FOLLOWING OUT OF RANGE IMPEDANCES: C <(>&<)> 0: 8675 0 <(>&<)> 3: >40000 C <(>&<)> 3: >40000 1 <(>&<)> 3: >40000 0 <(>&<)> 1: 7882 2 <(>&<)> 3: >40000 0 <(>&<)> 2: 7963 IT WAS ALSO REPORTED THAT DURING SURGERY, THE HEALTHCARE PROFESSIONAL IDENTIFIED THAT THE LEFT LEAD WAS MISSING CONTACT 3 COMPLETELY. THE PATIENT HAD THEIR BILATERAL EXTENSIONS AND IMPLANTABLE GENERATOR (IPG) REPLACED AND THE POCKET ADAPTER REMOVED. IT WAS MENTIONED THAT PRIOR TO SURGERY, THE PATIENT WENT INTO THE EMERGENCY ROOM WITH AN IPG AT END OF SERVICE (EOS). THE ISSUE WAS NOT SOLVED AT THE TIME OF THE REPORT. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT HAD DAMAGED LEADS CAUSING HIGH IMPEDANCES. THE LEADS AND EXTENSIONS WERE REPLACED. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PREVIOUS INFORMATION WAS CONFIRMED WITH THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1238987 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37601 | 00643169864191 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention | "SEE H10...." |