ACTIVA
Report
- Report Number
- 6000153-2014-00104
- Event Type
- Injury
- Date Received
- May 23, 2014
- Date of Event
- April 21, 2014
- Report Date
- May 6, 2014
- Manufacturer
- NEURO - VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0HSEK, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).
PRODUCT ID: 3387S-40, LOT# VA0HSEK, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0HSEK, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0HSEK, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD THE IMPLANT DONE ON (B)(6) 2014 AND HAD NOT RECOVERED WELL FROM THE SURGERY. PATIENT HAD CONTINUED SWELLING IN HIS BRAIN AROUND THE ENDS OF THE LEADS AND WAS VERY CONFUSED AND DISORIENTED. THE PATIENT WAS NOT DOING WELL. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONALS (HCP) HAD SAID THERE WAS SOME FUZZINESS IN THE IMAGES OF HIS BRAIN AT THE ENDS OF THE LEADS. THE PATIENT¿S FRIEND OR FAMILY MEMBER INQUIRED ABOUT THE TYPE OF METAL IS THAT IS EXPOSED ON THE LEADS IN CASE OF A POSSIBILITY OF AN ALLERGIC REACTION. IT WAS LATER REPORTED THAT THE PATIENT HAD NOT RETURNED TO NORMAL FUNCTIONS SINCE HAVING THE IMPLANTABLE NEUROSTIMULATOR (INS) PUT IT ON (B)(6) 2014. INQUIRED ABOUT METAL EXPOSED ON THE INS ALSO. THE CALLER THOUGHT THE PATIENT WAS HAVING AN ALLERGIC REACTION. IT WAS NOTED THAT THE PATIENT KNEW HIS NAME AND DATE OF BIRTH BUT NOT THE CURRENT DATE OR HOW TO COMMON OBJECTS. IT WAS NOTED THAT THE FRIEND OR FAMILY MEMBER THOUGHT THE PATIENT LOST A LOT OF FRONTAL LOBE FUNCTIONS. IT WAS NOTED THAT THERE WAS NO BRAIN DAMAGE. STIMULATION WAS NOT ON AND HAD NEVER BEEN TURNED ON FOR THE PATIENT. IT WAS LATER REPORTED PATIENT WAS HAVING NEGATIVE REACTIONS TO THE DEEP BRAIN STIMULATOR IMPLANTS. THE PATIENT WAS IMPLANTED ¿WITH THE BRAIN PART¿ ON (B)(6) 2014 AND HAD NOT LEFT THE HOSPITAL YET. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER¿S REPORT NUMBER: 6000153-2014-00103.
IT WAS LATER REPORTED THAT THERE WAS AN INFECTION. THERE WAS A RECENT FAILED IMPLANT DUE TO A MAJOR INFECTION. THE INFECTION ALMOST KILLED THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A DIAGNOSIS WAS NOT MADE REGARDING THE SUSPECTED ALLERGIC REACTION TO THE LEADS. THE TYPE OF CEREBRAL EDEMA WAS NOT DETERMINED, THE CAUSE WAS THE INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAD RECOVERED FROM THE INFECTION. AT THE PATIENT¿S LAST APPOINTMENT ON (B)(6) 2014 THE PATIENT HAD DENIED ANY CONTINUED COGNITIVE ISSUES OR THE THINGS HIS WIFE HAD SAID. THE PATIENT FELT GOOD AND WAS SHOWING CONTINUED IMPROVEMENT. SCAN SHOWED EDEMA HAD RESOLVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT ENDED UP LEAVING THE CLINIC AND GOING TO REHAB ON (B)(6) 2014. AN ABSCESS WAS FOUND AND THE PATIENT WAS PUT BACK ON INTRAVENOUS (IV) ANTIBIOTICS WHEN THE PATIENT HAD COME BACK ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT FELL AND WAS MAKING VERY SLOW IMPROVEMENTS. IT WAS NOTED THAT THE PATIENT¿S MENTAL STATUS STILL ¿WAXED AND WANED.¿ PATIENT¿S ALERTNESS AND SPEECH WAS IMPROVING. THE PATIENT WAS STILL NOT ABLE TO WALK INDEPENDENTLY. RECOVERY WAS VERY SLOW. THE PATIENT HAD IMAGING/MRI DONE ON (B)(6) 2014 WHICH WAS THE MOST RECENT SINCE IN THE HOSPITAL, STILL HAD BILATERAL EDEMA WITH ENHANCEMENT WITH SMALL ABSCESS IN THE RIGHT SUBTONIC REGION BUT THERE WAS SIGNIFICANT ¿INTERVAL¿ IMPROVEMENT SO IMPROVEMENT WAS SLOW BUT THERE WAS IMPROVEMENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNCERTAIN. IT WAS NOTED THAT SURGICAL INTERVENTION HAD OCCURRED ON (B)(6) 2014 AND THE LEAD, EXTENSION AND IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED. A MRI/X-RAY/CT SCAN WAS DONE ON (B)(6) 2014 AND RESULTS WERE A BIFRONTAL HYPODENSITIES SURROUNDING THE COURSE OF THE PATIENT¿S DEEP BRAIN STIMULATOR ELECTRODES. SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT WERE BEHAVIORAL DIFFICULTY WITH INAPPROPRIATE BEHAVIOR AND CONFUSION. THE PATIENT HAD REQUIRED HOSPITALIZATION AS A RESULT OF THE EVENT. THE PATIENT OUTCOME WAS NON-SERIOUS INJURY/ILLNESS. IT WAS NOTED THAT IT WAS QUESTIONABLE IF THERE WAS AN ALLERGIC RESPONSE. IT WAS UNCLEAR WHETHER THE INS AND EXTENSIONS WERE EVER IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308111 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3387S-40 | VA0HSEK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Hospitalization| R |