ACTIVA
Report
- Report Number
- 3004209178-2020-00855
- Event Type
- Injury
- Date Received
- January 11, 2020
- Date of Event
- December 20, 2019
- Report Date
- March 11, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00643169529762
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONTINUATION OF D11: PRODUCT ID 7482A51, SERIAL# (B)(6), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION, PRODUCT ID: 3387S-40, LOT# V023028, 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.
ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT HAD A BATTERY EXTENSION REPLACEMENT ON (B)(6) 2020 AND THE ISSUE SEEMED TO BE RESOLVED. THEY REPLACED THE BATTERY AND EXTENSION ON LEFT BODY. THE LEAD LOOKED KINKED WHEN THEY WENT TO DISCONNECT THE LEAD/EXTENSION. THEY SCREENED THE LEAD AND DID AN IMPEDANCE CHECK AND THAT CHECKED OUT FINE. PATIENT HAD SHOCKING ON ALL GROUPS. AFTER SURGICAL INTERVENTION THE ISSUE SEEMS TO BE RESOLVED. THIS INFORMATION WAS CONFIRMED WITH THE PHYSICIAN.
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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2020. PRODUCT TYPE EXTENSION, PRODUCT ID 3387S-40, LOT# V023028, IMPLANTED: (B)(6) 2007. EXPRODUCT TYPE LEAD IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT SEVERAL WEEKS AGO THE PATIENT DEVELOPED SOME ELECTRICAL TYPE ZAPPING SENSATION IN THEIR ARM THAT RESOLVED WHEN THEY SHUT OFF THE STIMULATOR. IT WOULD OFTEN TIMES TAKE ABOUT 10 MINUTES TO 40 MINUTES TO COME BACK WHEN IT WAS TURNED BACK ON. THIS WAS HAPPENING AT ALL LEVELS OF STIMULATION. THE DEVICE WAS INTERROGATED TWICE WITHOUT ANY ABNORMAL IMPEDANCES. THEY TRIED CHANGING THE STIMULATION PATTERN, WHICH DID NOT RESOLVE THE ISSUE. IT WAS STATED IT WAS UNKNOWN IF THIS WAS AN EXTENSION OR SOME OTHER COMPONENT THAT IS NOT SEEN WITH INTERROGATION. NO FALLS OR OTHER TRAUMA REPORTED. THE PATIENT WOULD GO TO A NEUROSURGEON TO SEE IF THEY HAVE OTHER SUGGESTIONS. IT WAS STATED THAT SOME X-RAYS OF THEIR NECK SHOW FAIRLY SEVERE CERVICAL DEGENERATIVE DISEASE, SO THIS MAY BE RADICULOPATHY THAT IS INDEPENDENT OF DBS, BUT IT SEEMED UNUSUAL THAT THIS ONLY HAPPENED WITH STIMULATION ON. IT WAS STATED TO STILL BE UNKNOWN IF THE ISSUE WAS "DEFINITELY DBS RELATED." ON 2020-01-09 ADDITIONAL INFORMATION WAS RECEIVED THAT THE MANUFACTURING REPRESENTATIVE (REP) SPOKE TO THE PATIENT AND THE PATIENT INDICATED THE SENSATION BEGAN (B)(6), 2019. THE ZINGING/SHOCKING SENSATION WAS ON THE RIGHT SIDE "RANDOMLY." IMPEDANCES WERE NORMAL WITH MULTIPLE DIFFERENT POSITIONS. THE ZINGING/SHOCKING WAS STATED TO BE AT EITHER 4V OR 0.5V, THE PATIENT STILL FEELS THE SENSATION. IT WAS INDICATED EITHER "SITTING ON THE COUCH, DRIVING, AT PATIENT'S MOM'S HOUSE, OR WALKING; UPRIGHT POSITION. IT WAS UNKNOWN IF THEY EXPERIENCED IT LYING DOWN. THE REP/PATIENT WERE REDIRECTED TO THE HCP.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF THE ¿ZINGING/SHOCKING/ZAPPING¿ SENSATION ON THE RIGHT SIDE WAS NOT YET KNOWN. THEY SUSPECTED IT MAY BE AN "INTERMITTENT CIRCUITRY ISSUE." THE NEUROLOGIST WAS MEETING WITH THE PATIENT TO PROGRAM ALL 4 CONTACTS, 1 PER GROUP, AND WILL HAVE THE PATIENT REPORT BACK TO SEE IF THE "ZINGING" HAPPENS ON A PARTICULAR GROUP. THEY ARE HOPING THIS "POINTS" TO THE INTERMITTENT SHORT. THE ISSUE IS NOT YET RESOLVED.
ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE DEVICE WASN¿T SENT BACK. THE PATIENT HAD A KINK AT THE LEAD/EXTENSION SITE WAS IDENTIFIED DURING THE EXTENSION AND BATTERY SWAP OUT. THE PATIENT HADN¿T REPORTED ANY ZINGING SINCE THEIR EXTENSION AND BATTERY REPLACEMENT. IT SEEMED AS THOUGH THE ISSUE HAD BEEN RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42175 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37612 | 00643169529762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | "SEE H10...."| "SEE H10...." |