ACTIVA
Report
- Report Number
- 3004209178-2013-02639
- Event Type
- Injury
- Date Received
- February 14, 2013
- Report Date
- January 17, 2013
- 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
(B)(4). ANALYSIS OF THE EXTENSION MODEL 7495-51 SERIAL (B)(4) FOUND BROKEN CONDUCTORS ON CIRCUITS 0-3 IN THE COILED WIRE 14CM FROM THE DISTAL END. THERE WERE OPEN CIRCUITS. ANALYSIS OF THE ADAPTOR MODEL 64001 LOT UNKNOWN FOUND NO ANOMALY.
(B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID, 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# VA02HC7, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0237085V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EXTENSION WITH THE SERIAL (B)(4) WAS THE EXTENSION THAT WAS REPLACED. THIS EXTENSION HAD BEEN CONNECTED TO THE INS WITH THE SERIAL (B)(4), WHICH WAS REPORTED ON IN MFR. REP. # 3004209178-2013-02632.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT FOLLOWING THE SURGERY THERE WAS NO INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD INTERMITTENT USAGE OF STIMULATION FOR THE PAST FEW YEARS, AND THE INS BATTERY WAS SHOWING 2.95V. THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND IMPEDANCE MEASUREMENTS OVER 40,000 OHMS WERE SEEN ON EVERY PAIR WITH CONTACT 3. ALL OTHER CONTACTS WERE ELEVATED, BUT WITHIN RANGE. THE HCP CONDUCTED AN EXPLORATORY SURGERY TO DETERMINE THE ISSUE AND FOUND THAT THE PROBLEM WAS WITH THE PATIENT'S LEFT EXTENSION. THE EXTENSION WAS REPLACED AND IMPEDANCES WERE IN NORMAL RANGE. THE SYSTEM WAS LEFT TURNED OFF UNTIL THE PATIENT COULD BE PROGRAMMED IN THE OUTPATIENT CLINIC.
IT WAS REPORTED THE HEALTH CARE PROFESSIONAL (HCP) WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THE DISPLAY WAS SHOWING "CALL YOUR DOCTOR" ICON. OUT OF REGULATION (OOR) WAS ALSO REPORTED. ONE DAY LATER IT WAS REPORTED THE PATIENT WAS NOT GETTING ANY THERAPY BENEFIT. IT WAS NOTED STIMULATION WAS ON. DURING REPORT THE PATIENT WAS IN THE OFFICE WITH THE HCP AND IT WAS NOTED THE STIMULATOR SHUT OFF BUT THE HCP WAS NOT SURE IF THEY HAD HIT SOMETHING OR IF IT HAD TURNED OFF BY ITSELF. IT WAS ALSO NOTED THERE WERE IMPEDANCES GREATER THAN 4,000 OHMS WITH ALL CONTACTS USING ELECTRODE 3. IT WAS NOTED THE PATIENT HAD BRUISING AND A FRESH SCAB OVER THE TOP OF THE BURR HOLE SITE. THE PATIENT HAD HIT THEMSELVES ON THE HEAD A WHILE AGO WHICH WAS WHY "THEY KNEW ABOUT THE BROKEN ELECTRODE". THE PATIENT DID NOT KNOW WHERE THE BRUISE HAD COME FROM, IT WAS NOTED IT POSSIBLE HAPPENED WHILE PLAYING WITH THEIR KIDS. TEN DAYS LATER IT WAS REPORTED THERE WERE ALSO LOW OUT OF RANGE IMPEDANCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE. REFER TO MANUFACTURER REPORT # 3004209178-2013-02632. PATIENT HAS BILATERAL SYSTEMS AND IT WAS UNCLEAR WHICH DEVICE PERTAINED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 64380 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |