ACTIVA
Report
- Report Number
- 3004209178-2014-13765
- Event Type
- Injury
- Date Received
- July 31, 2014
- Report Date
- July 11, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V279715, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V279715, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 64002, LOT # N241096, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2014, PRODUCT TYPE ADAPTER; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009-, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-29, SERIAL # UNKNOWN, PRODUCT TYPE ACCESSORY. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND ANOMALY. THE DEVICE IMPEDANCES WERE RUN AND NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.
PRODUCT ID 3387S-40, LOT# V279715, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40, LOT# V279715, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 64002, LOT# N241096, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION (B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V279715, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40 LOT # V279715, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 64002, LOT # N241096, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-29, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT¿S POCKET SITE WAS ¿SPASMING.¿ THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON THE NIGHT PRIOR TO THE DATE OF THIS REPORT DUE TO MUSCLE FATIGUE IN THE PECTORAL MUSCLES SURROUNDING THE POCKET. THE PROBLEM ONLY OCCURRED WHEN THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED ON. PATIENT HAD EXPERIENCED THIS SINCE MAY PRIOR TO THE DATE OF THIS REPORT WHEN THE INS HAD BEEN REPLACED. THE PROBLEM WAS PREVIOUSLY INTERMITTENT AND HAD NEVER BEEN AS SEVERE AS IT WAS ON THE NIGHT PRIOR TO THE DATE OF THIS REPORT. IMPEDANCES WERE IN RANGE BUT WERE NOT NORMAL. THE ISSUE WAS UNRESOLVED. IMPEDANCES FOR THE LEFT WERE C/0-1055 OHMS, C/1-910 OHMS, C/2-597 OHMS, C/3-1041 OHMS, 0/1-1296 OHMS, 0/2-1302 OHMS, 0/3-1784 OHMS, ½-1042 OHMS, 1/3-1607 OHMS AND 2/3-1293 OHMS. RIGHT IMPEDANCES WERE C/4-819OHMS, C/5-721 OHMS, C/6-402 OHMS, C/7-767 OHMS, 4/5-964 OHMS, 4/6-869 OHMS, 4/7-1171 OHMS, 5/6-740 OHMS, 5/7-1073 OHMS, 6/7-755 OHMS. THE LEFT WAS PROGRAMMED TO 2+1-, 2.8V, 90PW, 140HZ AND THERAPY IMPEDANCE WAS 1083 OHMS. RIGHT WAS PROGRAMMED TO 7+6-5+, 2.5V, 90PW, 140HZ AND THERAPY IMPEDANCE WAS 498 OHMS. HISTORICAL IMPEDANCES FROM RIGHT AFTER IMPLANT FOR THE LEFT WERE C/0-1421, C/1-1498, C/2-931, C/3-1160, 0/1-1911, 0/2-1872, 0/3-2172, ½-1645, 1/3-2204 AND 2/3-1615 AND FOR THE RIGHT WERE C/4-947, C/5-788, C/6-558, C/7-887, 4/5-1096,<(>,<)> 4/6-1106, 4/7-1406, 5/6-839, 5/7-1195 AND 6/7-890. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A REPLACEMENT OF THE SYSTEM AND NOW HAD A RECHARGEABLE DEVICE. THE EXPLANTED DEVICE WOULD BE RETURNED. SINCE THE REPLACEMENT THE PATIENT HAD NOT EXPERIENCED ANY SPASM AND ALL LEAD IMPEDANCES WERE NORMAL. PATIENT WAS RECEIVING EFFECTIVE THERAPY.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RIGHT SUBTHALAMIC NUCLEUS (STN) LEAD WAS SET OFF TO 0.0V TO PREVENT SPASMS IN THE POCKET. IT WAS NOTED THAT THE RIGHT STN WAS THE PROBLEMATIC SIDE. THERE WAS AN INTERROGATION OF THE SYSTEM PERFORMED WHICH HAD REVEALED ABNORMAL IMPEDANCES. THEY THOUGHT THERE WAS A SHORT IN THE SYSTEM BUT THEY WERE UNAWARE OF WHERE IT COULD HAVE DERIVED FROM. THE PATIENT WAS UNDERGOING EXPLORATORY SURGERY ON (B)(6) 2014 AND THEY MAY ALSO REPLACE THE PRIMARY CELL DEVICE WITH A RECHARGEABLE DEVICE. ONCE THE PATIENT WAS SET TO 0.0 VOLTAGE THE RIGHT SIDE WAS NO LONGER RECEIVING THERAPY ON THE RIGHT. THE PATIENT¿S LEFT SIDE WAS PERFECTLY FINE. IT WAS LATER REPORTED THE PATIENT HAD RECEIVED A NEW BATTERY ON (B)(6) 2014 DUE TO BATTERY DEPLETION. THE IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS PUT IN (B)(6) WAS DEFECTIVE BECAUSE IT WAS CAUSING THE PATIENT SPASMS. THE PATIENT HAD NOTICED INTERMITTENT SPASM BUT HAD THOUGHT IT WAS PART OF THE HEALING PROCESS. THE PATIENT WAS IN THE EMERGENCY ROOM ON THE NIGHT OF (B)(6) 2014 BECAUSE SHE WAS NOT ABLE TO STOP SPASMING AND THEY HAD TO TURN THE DEVICE OFF. THE PATIENT WAS IN A CONSTANT AND COMPLETE SPASM THAT WAS NONSTOP. THE PATIENT WAS ADMITTED DUE TO SYMPTOMS BEING BACK UNCONTROLLABLY. PATIENT WAS SHAKING SO BAD. THE INS WAS TAKEN OUT ON (B)(6) 2014 AND A NEW INS WAS PUT IN. PATIENT¿S SYMPTOMS WERE RELIEVED AND SHE WAS NOT EXPERIENCING ANY ISSUES WITH THE NEW INS. PATIENT WAS ON DISABILITY. IT WAS LATER REPORTED THAT AFTER THE REPLACEMENT IN (B)(6) 2014 THE MUSCLE IN THE AREA OF THE INS WOULD SPASM. IT WAS NOTED THAT HAD BEGUN TO HAPPEN MORE AND MORE FREQUENTLY. IT WAS STATED THAT IT WAS LIKE WHEN GUYS FLEX THEIR PECTORAL MUSCLES. THE PATIENT SAW THEIR HEALTHCARE PROFESSIONAL ON (B)(6) 2014 AND THEN HAD GONE TO WORK AND PEOPLE WERE FREAKING OUT AND IT WAS PAINFUL. THE PATIENT WAS TALKED INTO GOING TO THE EMERGENCY ROOM. SPASMS WENT AWAY WHEN THE INS WAS TURNED OFF. THE TREMOR HAD COME BACK VENGEANCE AND THE PATIENT HAD TO HAVE MEDICATION THAT HAD MADE HER FEEL LIKE A ZOMBIE TO KEEP THE TREMOR UNDER CONTROL. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WOULD RETURNED AND THE DEVICE WAS REPLACED. THE REASON FOR REMOVAL WAS THERAPY RELATED, SPASMS IN CHEST WHEN THERAPY WAS ON. THE PATIENT HAD RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446875 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00042 YR | Hospitalization| R |