ACTIVA
Report
- Report Number
- 3004209178-2014-11604
- Event Type
- Injury
- Date Received
- June 16, 2014
- Report Date
- May 29, 2014
- 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37601, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V765533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37601, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION.
PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: 2011 (B)(6); PRODUCT TYPE EXTENSION (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37601, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60 LOT# SERIAL# NKN020501V IMPLANTED: 2014-06-11 EXPLANTED: PRODUCT TYPE EXTENSION
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V765533, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID 37601, SERIAL# (B)(4), PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. ANALYSIS OF THE EXTENSIONS FOUND THE PROXIMAL END CONNECTOR NOT COMPLETELY SEATED IN INS CONNECTOR PORT. SOME SET SCREW MARKS WERE TOO PROXIMAL WHICH INDICATED THAT THE EXTENSION WAS NOT FULLY INSERTED. ONE SET OF SET SCREW MARKS APPEARED TO BE IN THE CORRECT LOCATION.
IT WAS LATER REPORTED THAT THE PATIENT HAD RETURNED FOR FOLLOW-UP AFTER THE BATTERY REPLACEMENT. ABNORMAL IMPEDANCES WERE OBTAINED DURING SURGERY THAT HAD BEEN VARIABLE BUT HAD ENDED UP WITH ONE ABNORMAL CONTACT, CONTACT 3 ON THE LEFT LEAD AND ALL BUT ONE CONTACT ON THE RIGHT LEAD WERE ABNORMAL. IT HAD BEEN VARIABLE DURING SURGERY SO AN ACTUAL PROBLEM WAS UNCLEAR. THE PATIENT HAD RETURNED FOR A SECOND VISIT AND IMPEDANCES WERE THE SAME. THEY HAD BEEN UNABLE TO MAKE "HEADWAY" AGAINST THE PATIENT'S SYMPTOMS. THE PATIENT HAD EXCELLENT SYMPTOM CONTROL PRIOR TO REPLACEMENT. IT WAS NOTED THAT TREMOR HAD BEEN THE BIGGEST COMPLAINT BUT HAD BEEN WELL CONTROLLED WITH THE STIMULATOR. ALL CONTACTS ON THE LEFT LEAD EXCEPT CONTACT 3 WERE WORKING. CONTACT 3 WAS THE 1 CONTACT THAT WAS EFFECTIVE FOR THE PATIENT'S TREMOR. THERE WAS NO INDICATION OF DAMAGE TO THE EXTENSION. PATIENT WAS NOT GETTING BENEFIT. THERE WAS AN ELECTRICAL CONNECTIVITY ISSUE. IT WAS RECOMMENDED THAT THE GENERATOR OR EXTENSIONS BE REPLACED. THE DEVICE HAD NOT DONE WHAT IT WAS SUPPOSED TO DO. THE PROCEDURE WAS A REPLACEMENT ON (B)(6) 2014. FACILITY MEDWATCH, (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RECEIVING BETTER THERAPY. THE DEVICE WAS STILL WITH THE HOSPITAL RISK MANAGEMENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE ISSUES RELATED TO THE DEEP BRAIN STIMULATOR. THERE WAS A BATTERY ADJUSTMENT. THE SYMPTOMS HAD PERSISTED SO THE DEVICE WAS REMOVED. THE STIMULATOR HAD NOT BEEN HAVING AN EFFECT ON SYMPTOMS AS PREVIOUSLY NOTED AND EXPERIENCED. THE PATIENT'S BATTERY CHANGE WAS A FEW WEEKS PRIOR TO THE DATE OF THIS REPORT AND INTRA-OPERATIVE IMPEDANCE CHECKS HAD REVEALED HIGH IMPEDANCES ON 3 CONTACTS ON ONE SIDE AND 1 CONTACT ON THE OTHER SIDE. THE PATIENT HAD GONE BACK IN A COUPLE OF WEEKS LATER AND HAD EXTENSIONS REPLACED.
IT WAS REPORTED THAT THERE WERE IMPEDANCE READINGS THAT WERE GREATER THAN 40,000 OHMS. THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED ON THE DATE OF THIS REPORT AND THE NEW INS WAS SHOWING HIGH IMPEDANCES OF GREATER THAN 40 ,000 OHMS ON BOTH SIDES. IT WAS NOTED THAT INS WAS CLEANED OFF, RECONNECTED MULTIPLE TIMES AND TRIED TO SUCTION BUT STILL HAD HIGH IMPEDANCES ON BOTH SIDES. LEFT SIDE C/3, 0/3, 1/3, 2/3 WERE ALL GREATER THAN 40,000 AND ALL OTHER CONTACTS WERE OK. THE LEFT SIDE WAS PROGRAMMED FOR C/2 AND C/3, THERAPY IMPEDANCES WAS 864 OHMS. C/2 WAS 871 OHMS AND THE PATIENT WAS GETTING SOME TREMOR CONTROL BUT IT WAS NOT OPTIMAL. RIGHT SIDE C/8 WAS NORMAL AND ALL OTHER CONTACTS HAD HIGH IMPEDANCE. THE RIGHT SIDE WAS PROGRAMMED FOR C+10-9- AND THERAPY IMPEDANCE WAS HIGH. THE PATIENT WAS NOT RECEIVING TREMOR CONTROL ON THE RIGHT SIDE. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE WOULD TRY TO PROGRAM FOR C/8. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL EXPERIENCING TREMOR ON BOTH SIDES. IT WAS NOTED THAT THE PATIENT WAS GOING TO SEE THE HEALTHCARE PROFESSIONAL ON THURSDAY (B)(6) 2014 TO RE-EVALUATE AND DECIDE IF THEY NEEDED TO SCHEDULE SURGERY TO LOOK AT THE EXTENSION OR BATTERY B. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT WAS SCHEDULED TO HAVE SURGERY ON (B)(6) 2014 TO REPLACE THE BATTERY AND OR THE EXTENSIONS. IT WAS LATER REPORTED THAT THE PATIENT WAS GOING INTO THE OPERATING ROOM ON (B)(6) 2014. IMPEDANCES CONTINUED TO SHOW GREATER THAN 40,000OHMS AND HAD NOT RESOLVED OVER TIME. THE PREVIOUS ELECTRODE IMPEDANCE WAS AVERAGING 585 OHMS RUNNING AT 3V. INQUIRED IF IT WAS THE INS THAT WAS CAUSING THE HIGH IMPEDANCE AND NOTED THAT ONLY THE INS HAD BEEN CHANGED OUT PREVIOUSLY. THE HEALTHCARE PROFESSIONAL WENT BACK IN SURGICALLY AND REPLACED THE EXTENSION AND IT WORKED FINE. IT WAS NOTED THAT THE PRIMARY CELL INS WAS REPLACED DUE TO NORMAL BATTERY DEPLETION ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 352939 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Required Intervention |