ACTIVA
Report
- Report Number
- 3004209178-2012-10632
- Event Type
- Injury
- Date Received
- November 21, 2012
- Report Date
- October 25, 2012
- 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
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
(B)(4).
(B)(4).
PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V813689, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V813689, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT WHEN THE INS WAS IMPLANTED ON (B)(6)-2012, THE INS WAS COMING OUT OF THE PATIENT'S CHEST. IT WAS STATED THAT THE PATIENT COULD "SEE THE SILVER STICKING OUT".
IT WAS REPORTED THAT ONE OF THE PATIENT'S DEVICE POCKETS WAS SWOLLEN. IT WAS NOTED THAT THERE HAD ALWAYS BEEN A BUMP, BUT THE SWELLING HAD GOTTEN WORSE. IT WAS ALSO NOTED THAT "IT WAS NOT PUT IN RIGHT." IT WAS FURTHER REPORTED THAT THE POCKET IS HOT AND THE PATIENT'S RIGHT HAD WAS "A LITTLE STIFF." IT WAS ALSO NOTED THAT OTHER THAN THE ABOVE ISSUES THE PATIENT THERAPY WAS "GOING WELL" AND HIS TREMORS WERE UNDER CONTROL. APPROXIMATELY A MONTH LATER IT WAS REPORTED THAT THE DEVICE IN THE PATIENT'S LEFT SIDE WAS STICKING OUT. IT WAS NOTED THAT THE PATIENT HAD GONE TO THE HOSPITAL ON (B)(6) 2012 BECAUSE OF HIS DEVICE. IT WAS FURTHER REPORTED THAT IT WAS "ALL RED" UNDER THE BATTERY PACK. IT WAS NOTED THAT THE PATIENT WAS TESTED FOR INFECTION WHILE IN THE HOSPITAL AND IT WAS DETERMINED THAT IT WAS NOT INFECTED. IT WAS ALSO REPORTED THAT THE "THE HEALTH CARE PROVIDER (HCP) NOTICED BATTERY PACK WAS PLACED WRONG." IT WAS ALSO NOTED THAT THE PATIENT'S THERAPY WAS STILL WORKING AND THAT "THIS THING WAS A STEADY AS A ROCK" AND "IT WORKED LIKE CLOCKWORK.' IT WAS ALSO NOTED THAT HCP HAD TOLD THE PATIENT THAT THE DEVICE NEEDED TO BE REMOVED OR "YOU WILL CONSTANTLY BE IN HERE WITH THE THREAT OF INFECTION." IT WAS ALSO NOTED THAT "THE WHOLE BATTERY PACK IS STICKING OUT, IT WAS LIKE HE HAD A BREAST HANGING OVER HIS RIGHT NIPPLE, IT WAS VERY PRONOUNCED." IT WAS ALSO REPORTED THAT THE DEVICE "STARTED STICKING OUT THE DAY HE HAD IT DONE" AND "IT JUST GOT WORSE." THE RIGHT SIDE HAD GOTTEN BETTER BUT THE PATIENT HAD BEEN TOLD BY HIS HCP "IT WAS STILL NOT GOOD, IT WAS NOT DONE RIGHT." IT WAS REPORTED "THE RIGHT SIDE IS NOT IRRITATING HIM OR GETTING RED OR BLACK." IT WAS UNCLEAR IF THE PATIENT WAS HAVING ISSUES WITH ONE OR BOTH OF THEIR IMPLANTED DEVICES AND WHICH SYMPTOM PERTAINED TO WHICH DEVICE. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3004209178-2012-10627.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN INFECTION. WHEN THE PATIENT WAS HOSPITALIZED FOR POSSIBLE INFECTION, THEY WERE "LOADED WITH ANTIBIOTICS, BUT THE WHITE BLOOD COUNT WAS NEVER ELEVATED." IT WAS STATED THE DEVICE WAS EXPLANTED BECAUSE IT WAS "PROTRUDING FROM THE SKIN." THE PATIENT HAD BEEN ON ANTIBIOTICS FOR ONE MONTH. IT WAS INDICATED THE PATIENT HAD AN APPOINTMENT WITH THE HEALTHCARE PROVIDER ON (B)(6) 2012 TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) "PUT BACK IN." ABOUT TWO WEEKS LATER, IT WAS REPORTED THE INS HAD BEEN REPLACED AND WAS "WORKING AS DESIGNED." A LITTLE MORE THAN A WEEK LATER IT WAS STATED THE PREVIOUS INS WAS REPLACED DUE TO INFECTION. IT WAS ALSO STATED THAT NO MALFUNCTIONS WERE SEEN AT THE TIME OF REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PHYSICIAN FIRST SAW THE PATIENT ON (B)(6) 2012. A CULTURE WAS TAKEN FROM THE POCKET AND REVEALED (B)(6). THE PATIENT EXPERIENCED REDNESS, SWELLING, DRAINAGE, INCISIONAL WOUND OPENING, AND POCKET EROSION. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND THE INFECTION RESOLVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HIS DEVICE OR THERAPY. HOWEVER, THE FOLLOWING DAY IT WAS REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HIS DEVICE OR THERAPY BUT HAD SOUGHT FURTHER HELP. THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2013.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A DEVICE MAY HAVE BEEN INFECTED THE 'DAY IT WAS PUT IN.' IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PUT IN THE WRONG PLACE AND THE DEVICE ERODED THROUGH THE PATIENT'S SKIN. THE REPORTER STATED THAT IT WAS LIKE A 'BIG GIGANTIC LUMP THAT NEVER WENT DOWN.' IT WAS REPORTED THAT THE PATIENT'S DOCTOR SAID TO GIVE IT MORE TIME TO GO DOWN, BUT IT NEVER DID. THE REPORTER STATED THAT BY (B)(6) 2012 THE DEVICE SITE STARTED TO GET RED AND LOOK BAD, AND THE PATIENT WAS TOLD BY THE DOCTOR THAT THE DEVICE HAD TO BE TAKEN OUT. IT WAS REPORTED THAT THE DEVICE WAS TAKEN OUT AND A NEW ONE WAS PUT IN. SEE INFORMATION RELATED TO THE PATIENT'S REPLACEMENT DEVICE IN MFR. REPORT #3004209178-2013-04952.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Hospitalization| R |