ACTIVA
Report
- Report Number
- 6000153-2013-00064
- Event Type
- Injury
- Date Received
- April 11, 2013
- Report Date
- March 22, 2013
- Manufacturer
- NEURO - VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
(B)(4).
(B)(4).
PRODUCT ID 3387S-40 LOT# V813689, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37603 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3708640 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 37603 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT "HEARD EVERYTHING THAT WAS GOING ON" DURING THE IMPLANT PROCEDURE. IT WAS REPORTED THAT A PATIENT'S BRAIN WAS DAMAGED WHEN THE DEVICE WAS PUT IN AND THE PATIENT HAD A "BRAIN BLEED" AND WAS UNABLE TO REMEMBER THINGS FOR OVER A MONTH AFTER THE DEVICE WAS IMPLANTED. THE REPORTER STATED THAT THE PATIENT'S MEMORY CAME BACK BUT HE STILL HAD DAMAGE WITH SPEECH AND EMOTIONAL FEELING LOSS. IT WAS INDICATED THAT THE PATIENT HAD A STROKE DURING THE PROCEDURE.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO MENTION OF DIFFICULTY IN PLACING THE LEAD IN THE OPERATIVE NOTE AND THE OPERATION WENT SMOOTHLY. IT WAS NOTED THAT THE PATIENT HAD A CAT SCAN IMMEDIATELY FOLLOWING THE SURGERY AND NOTHING UNUSUAL WAS SEEN. IT WAS REPORTED THAT THE PATIENT¿S MENTAL STATUS CHANGED ONE DAY POST-OPERATIVELY AND THE PATIENT DEVELOPED A HEMORRHAGE IN THE LEFT FRONTAL LOBE. THE NEXT STAGE OF THE SURGERY WAS POSTPONED WHILE THE PATIENT RECOVERED, AND THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2012. IT WAS REPORTED THAT A SUBSEQUENT CAT SCAN WAS DONE ON (B)(6) 2012 AND NO HEMORRHAGE OR MASS EFFECT WAS FOUND. IT WAS NOTED THAT THE PATIENT HAD THE NEXT STAGE OF SURGERY A MONTH AFTER THE FIRST STAGE OF SURGERY AND THE PATIENT HAD A GOOD RESPONSE FROM PROGRAMMING.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD ONE LEAD AND ONE IMPLANTABLE NEUROSTIMULATOR (INS) ON THEIR RIGHT SIDE. THE PATIENT HAD A LEAD PLACED IN THE BRAIN ON THE DAY BEFORE THE REPORT. THE LEFT LEAD WAS NOT YET CONNECTED TO AN INS. IT WAS STATED THAT ON (B)(6) 2012 THEY "HIT A VEIN" AND THAT GAVE THE PATIENT A "BRAIN BLEED" WHICH CAUSED THE PATIENT TO HAVE MEMORY LOSS AND HE "ENDED UP HAVING A STROKE". IT WAS REPORTED THAT THE PATIENT RECENTLY HAD AN INS REMOVED ON (B)(6) 2013 AND THE PATIENT HAD A "DEEP BONE SCAN". IT WAS STATED THAT "AFTER HE DRANK THE LIQUID, IT CAUSED HIS MOUTH AND EYES TO DROOP". IT WAS NOT CLEAR WHAT LIQUID THE REPORTER WAS REFERRING TO. IT WAS STATED THAT "EVER SINCE THEN THE PATIENT HAD BEEN FALLING A LOT". IT WAS REPORTED THAT "RIGHT AFTER HE TOOK THE TEST THEY BROUGHT HIM TO THE HOSPITAL". IT WAS NOTED THAT "THEY COULDN'T FIND ANYTHING WRONG WITH HIM". IT WAS REPORTED THAT THE HEALTH CARE PROVIDER THOUGHT THAT THE PATIENT "MIGHT HAVE HAD A MINI STROKE".
ADDITIONAL REVIEW DETERMINED PART OF THIS EVENT WAS REPORTED IN MANUFACTURER REPORT 3004209178-2013-04952. ANY ADDITIONAL INFORMATION REGARDING THE PATIENT'S WOUND NOT HEALING WILL BE REPORTED IN THIS MANUFACTURER REPORT NUMBER. THE EVENT PREVIOUSLY REPORTED INCLUDED THE EVENT THAT OCCURRED AFTER THE ¿DEEP BONE SCAN¿ TO DETERMINE IF THE BONE WAS INFECTED AND ¿AFTER HE DRANK THE LIQUID.¿ IT WAS REPORTED IT CAUSED HIS MOUTH AND EYES TO DROOP". IT WAS NOT CLEAR WHAT LIQUID THE REPORTER WAS REFERRING TO. IT WAS STATED THAT "EVER SINCE THEN THE PATIENT HAD BEEN FALLING A LOT". IT WAS REPORTED THAT "RIGHT AFTER HE TOOK THE TEST THEY BROUGHT HIM TO THE HOSPITAL". IT WAS NOTED THAT "THEY COULDN'T FIND ANYTHING WRONG WITH HIM.¿ IT WAS REPORTED THAT THE HEALTH CARE PROVIDER THOUGHT THAT THE PATIENT "MIGHT HAVE HAD A MINI STROKE.¿
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S DOCTOR "TOOK MONEY FROM THEM" FOR PSYCHOLOGICAL EXAMS. IT WAS NOT CLEAR EXACTLY WHAT THAT MEANT. IT WAS STATED THAT THE PATIENT HAD A "3 POINT BONE SCAN" AND THERE WAS "NOTHING NEW". IT WAS REPORTED THAT BECAUSE THE "EMOTIONAL AREA OF THE BRAIN WAS HIT", IT AFFECTED THAT THE PATIENT'S JOB AND HE COULD NOT GO BACK TO IT. IT WAS STATED THAT THE PATIENT "MIGHT HAVE HAD A BRAIN STROKE ON (B)(6) 2013, A WEEK BEFORE THAT BECAUSE HIS FACIAL". IT WAS ALSO NOT CLEAR WHAT THAT MEANT. IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE A LEAD IMPLANTED ON (B)(6) 2013 AND THE INS IMPLANTED ON (B)(6) 2013.
IT WAS REPORTED THAT THE "HOLE THE THING WAS SUPPOSED TO GO THROUGH" WAS MISSED AND "PUNCHED INTO THE PATIENT'S BRAIN" WHICH CAUSED THE PATIENT TO HAVE A BRAIN BLEED. THIS "DAMAGED" THE PATIENT'S BRAIN AND CAUSED HIM TO LOSE HIS MEMORY FOR ABOUT A MONTH. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156481 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | NEURO - VILLALBA | 3387S-40 | V813689 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Hospitalization| O |