ACTIVA
Report
- Report Number
- 3004209178-2016-19733
- Event Type
- Malfunction
- Date Received
- September 26, 2016
- Date of Event
- September 7, 2016
- Report Date
- November 14, 2016
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
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.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V050275, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4). 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.
THE PATIENT REPORTED VIA A MANUFACTURER REPRESENTATIVE (REP) THAT HE HAD A RETURN OF SYMPTOMS ON (B)(6) 2016. AN IMPEDANCE TEST WAS TAKEN ON (B)(6) 2016 AND THERE WAS A CLINIC VISIT ON THE DAY OF THE EVENT. A CT SCAN WAS TAKEN DURING THE CLINIC VISIT AND IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL EFFECTS. IT WAS NOTED THAT SURGICAL INTERVENTION WOULD OCCUR IN THE FUTURE AND THE ISSUE WAS NOT RESOLVED. THE PATIENT'S INDICATION(S) FOR USE WERE DBS.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT AFTER REPLACING THE EXTENSIONS AND IMPLANTABLE NEUROSTIMULATOR (INS), THE IMPEDANCES WERE STILL HIGH SO THE ASSUMPTION WAS MADE THAT THE LEAD WAS THE SOURCE. THE REP HAD NO DETAILS ON WHAT WAS SEEN INSIDE THE EXTENSION. THE PATIENT EVENTUALLY HAD A LEAD REVISION ON (B)(6) 2016. THE NEW LEAD WAS CONNECTED TO THE EXTENSION AND ALL IMPEDANCES SHOWED NORMAL READINGS.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT REPORTED TO HIS HEALTHCARE PROVIDER (HCP) THAT HE DID NOT FEEL THAT HIS STIMULATION WAS WORKING AS WELL AS BEFORE. AN IMPEDANCE CHECK WAS PERFORMED, WHICH SHOWED HIGH IMPEDANCES. THE HCP DID AN X-RAY AND THEY THOUGHT THEY SAW SOMETHING IN THE EXTENSION, SO THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2016 TO REPLACE THE EXTENSION. IN THE OR, THEY TESTED JUST THE LEAD AND HIGH IMPEDANCES WERE SEEN, BUT THEY WERE NOT IN A POSITION TO REPLACE THE LEAD THAT DAY, SO ONLY THE EXTENSION WAS CHANGED OUT. THE HIGH IMPEDANCES RANGED FROM 4,600 TO 14,000 OHMS AND ALL OF THE MONOPOLAR READINGS WERE OVER 10,000 OHMS. THE GROUP OR THERAPY IMPEDANCE WAS 2,600 OHMS. THE HCP WANTED TO CHANGE THE PATIENT FROM CONSTANT VOLTAGE TO CONSTANT CURRENT MODE TO TRY AND OVERCOME THE HIGH IMPEDANCES, BUT THEY WERE GETTING THE MESSAGE DURING PROGRAMMING THAT THE PROGRAMMED SETTINGS COULD NOT BE USED. THE REP HAD SWITCHED TO CONSTANT CURRENT MODE AND PROGRAMMED TO CASE <(>&<)> 2 ON PROGRAM 1 AND TO CASE <(>&<)> 1 ON PROGRAM 2. WHEN THE REP TRIED TO INCREASE AMPLITUDE ON PROGRAM 1 THEY COULD NOT GO FROM 1.3 TO 1.4 MA AND WHEN TRYING TO INCREASE ON PROGRAM 2 THEY COULD NOT GO FROM 1.6 TO 1.7 MA. THE IMPEDANCE OF CASE <(>&<)> 2 WAS 7,238 OHMS AND THE IMPEDANCE OF CASE <(>&<)> 1 WAS 6,191 OHMS. IT WAS REVIEWED THAT THESE IMPEDANCES WERE THE REASON FOR THE MESSAGE APPEARING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 628039 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |