ACTIVA
Report
- Report Number
- 3004209178-2013-00962
- Event Type
- Injury
- Date Received
- January 25, 2013
- Report Date
- January 2, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NURSE
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 748351, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# VA035YF, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# VA02XPF, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS AN OPEN CIRCUIT ON THE ZERO CONTACT THAT ¿CAME THAT WAY.¿ IT WAS NOTED THAT THE PATIENT HAD BEEN PROGRAMMED MULTIPLE TIMES AND THE HEALTHCARE PROVIDER WAS HAVING TROUBLE GETTING BENEFIT ON THAT SIDE OF THE BODY AND THE OTHER SIDE OF THE BODY WAS ¿AWESOME.¿ IT WAS REPORTED THAT WHEN THE ZERO CONTACT WAS USED FOR PROGRAMMING THE PATIENT SEEMED TO BE GETTING SOME BENEFIT AND THE HEALTHCARE PROVIDER THOUGHT SHE MIGHT BE GETTING MORE BENEFIT ON THE ZERO CONTACT THAN SOME OF THE OTHER CONTACTS. THE REPORTER STATED THAT WHEN THE PATIENT WAS GIVEN AN OPTION, SHE WOULD PICK THE PROGRAM WITH THE ZERO CONTACT. IT WAS NOTED THAT NUMEROUS SETTINGS WERE TRIED FOR THE PATIENT. THE REPORTER STATED THAT ON THE ZERO CONTACT, IMPEDANCES SOMETIMES CHANGED FROM OVER 40,000 OHMS TO AROUND 30,000 OHMS, AND THEN THEY¿D GO BACK TO 40,000 OHMS. IT WAS NOTED THAT THE DEVICE WITH IMPEDANCE ISSUES WAS ¿IN THE RIGHT SIDE OF HER BODY¿ AND ¿IN HER LEFT BRAIN.¿ IT WAS UNCLEAR WHICH DEVICE THIS REFERRED TO. IT WAS NOTED THAT PRIOR TO IMPLANT THE PATIENT WAS VERY ILL, WASN¿T EATING AND WAS AT (B)(6) AND ¿EVEN WITH HALF OF IT WORKING¿ THE PATIENT WAS ¿INTO THE (B)(6)¿ AND WAS DOING BETTER. IT WAS REPORTED THAT THE SURGEON ¿DIDN¿T WANT TO MESS WITH¿ THE PATIENT AND WANTED THE HEALTHCARE PROVIDER WHO PROGRAMMED THE DEVICE TO ¿FIX IT.¿ THE REPORTER STATED THAT IN THE OPERATING ROOM IMPEDANCES WERE IN A NORMAL RANGE, BUT LATER ¿EVERYTHING THAT TOUCHED THE ZERO WAS REALLY HIGH.¿ IT WAS REPORTED THAT THE HEALTHCARE PROVIDER COULDN¿T USE THE PATIENT PROGRAMMER THE FIRST DAY OF PROGRAMMING BECAUSE OF THE OPEN CIRCUIT AND GOT AN ERROR MESSAGE, BUT IT WAS UNCLEAR WHAT THE ERROR MESSAGE WAS AND THE HEALTHCARE PROVIDER DIDN¿T HAVE AN ¿OUT OF REGULATION¿ (OOR) MESSAGE. IT WAS UNCLEAR IF THERE WAS EVER AN OOR MESSAGE AS IT WAS PREVIOUSLY REPORTED THAT THE HEALTHCARE PROVIDER SAW AN OOR MESSAGE. IT WAS NOTED THAT THE PATIENT ¿DIDN¿T MESS WITH¿ THE PATIENT PROGRAMMER ¿TOO MUCH ANYMORE.¿
IT WAS REPORTED STIMULATION WAS UNABLE TO BE ADJUSTED. AN OUT OF REGULATION CONDITION WAS REPORTED ALONG WITH A 'CALL YOUR DOCTOR' ICON. IT WAS NOTED THAT IMPEDANCES APPEARED TO BE NORMAL. THE PATIENT WAS PROGRAMMED USING CONSTANT CURRENT MODE. THE PROGRAMMING PARAMETERS WERE AS FOLLOWS: 3V, 120PW, 100HZ, AND C+0-. THE IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED IN THE PATIENT'S ABDOMEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS STATED THAT THE IMPEDANCES WERE GREATER THAN 40,000 OHMS ON CIRCUITS C-0, 0-1, 0-2, 0-3. THERE WAS AN OPEN CIRCUIT ON CONTACT #0 UPON INITIAL PROGRAMMING IN THE OPERATING ROOM. IT WAS UNKNOWN IF THIS WAS AN IMPLANTABLE NEUROSTIMULATOR (INS) ISSUE OR AN ISSUE WITH LEADS/EXTENSION. NO SURGICAL INTERVENTION HAS HAPPENED YET. IT WAS NOTED THAT THE CONTACT WAS STILL OPEN WHEN THE PATIENT WENT IN FOR PROGRAMMING ON THEIR SECOND VISIT. IT WAS REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED AND THE PATIENT OUTCOME WAS NON-SERIOUS INJURY/ILLNESS. NO FURTHER INFORMATION WAS PROVIDED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING A REVISION ON (B)(4)-2013 DUE TO "A POSSIBLE OPEN ON CONTACT 0 OF THE LEFT SYSTEM". IT WAS NOTED THAT THE IMPEDANCES HAD BEEN GOOD AT THE TIME OF IMPLANT. NO FURTHER DETAILS WERE PROVIDED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PROCEDURE WAS DONE ON THE DATE OF THIS REPORT IN RESPONSE TO OPEN CIRCUIT THAT THE PATIENT HAD WITH #0 ELECTRODE. IT WAS LATER REPORTED THAT THE ISSUE WAS THE EXTENSION/IMPLANTABLE PULSE GENERATOR CONNECTION. THE SURGEON FELT LIKE THERE WAS NOT AS MUCH RESISTANCE WHEN LOOSENING THE SCREWS AND IT WAS LIKE THAT FOR ALL 4 SCREWS. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT AFTER RECONNECTING THE EXTENSION TO IMPLANTABLE PULSE GENERATOR, ALL IMPEDANCES WERE ¿NORMAL.¿ IT WAS REPORTED THAT ¿THE CONTACT THAT WAS HELPING BEFORE THE ISSUE AROSE¿ OR ¿THE CONTACT THAT WAS FIXED¿ WOULD BE REPROGRAMMED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR DID NOT KNOW IF THE PREVIOUSLY REPORTED ¿THERE WAS NOT AS MUCH RESISTANCE WHEN LOOSENING THE SCREWS¿ WAS ¿WHAT THE PROBLEM IS.¿ THE DOCTOR THOUGHT IT WAS STRANGE AND DIFFERENT FROM WHAT HE HAD HISTORICALLY SEEN WHEN DOING AN IPG REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 35738 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | Required Intervention |