ACTIVA
Report
- Report Number
- 3004209178-2012-11787
- Event Type
- Injury
- Date Received
- December 13, 2012
- Report Date
- December 18, 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
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 64002, LOT # N320010, IMPLANTED: (B)(4) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER, PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # VA00WWZ, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # VA00WWZ, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
FINAL ANALYSIS OF THE EXTENSION (B)(4) REVEALED THE EXTENSION BODY OUTER INSULATION HAD A BREACHED DEPRESSION. FINAL ANALYSIS OF THE EXTENSION (B)(4) REVEALED NO ANOMALY FOUND. FINAL ANALYSIS OF THE ADAPTOR REVEALED NO ANOMALY FOUND.
PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 64002, LOT # N320010, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # VA00WWZ, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # VA00WWZ, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION ON THE LEFT HAND, LEFT SIDE OF HIS BODY AND LEFT LEG, WHICH DID NOT OCCUR WHEN STIMULATION WAS OFF. MOVEMENT WAS INDICATED TO CAUSE STIMULATION CHANGES; THE SHOCKING ONLY OCCURRED WITH CERTAIN MOVEMENT OF THE HEAD, SPECIFICALLY IF THE PATIENT TURNED HIS HEAD TO THE LEFT. IT WAS STATED THAT THE PATIENT WAS GETTING STIMULATION BENEFIT FOR ESSENTIAL TREMOR (ET) BUT MAY HAVE HAD SOME PROGRAMMING RELATED PARESTHESIAS. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. SIX DAYS LATER, IT WAS REPORTED THAT THE PATIENT RANDOMLY GOT A PARESTHESIA FEELING ON THE LEFT SIDE OF HIS BODY, WHICH WAS DESCRIBED AS "SHOCKING/SURGING" AS WELL. THIS WAS NOTED TO HAVE OCCURRED AFTER THE PLACEMENT OF AN ACTIVA PC AND ADAPTOR. ALL ELECTRODE IMPEDANCE VALUES WERE REPORTED TO BE NORMAL, EXCEPT ON THE RIGHT LEAD AT ELECTRODE BIPOLE 6-7 WHICH HAD AN IMPEDANCE VALUE OF 257OHMS WHEN TESTED AT 3.0V. PALPATION WAS DONE ALONG THE POCKET AREA AND THAT IMPEDANCE WENT DOWN TO 127OHMS, WHICH INDICATED A SHORT. THE PATIENT WAS PROGRAMMED ON C+,7- AT THE TIME. THE FOLLOWING DAY IT WAS INDICATED THAT THE PATIENT WAS HAVING AN IMPEDANCE ISSUE ON HIS RIGHT BRAIN ELECTRODE, "MOST LIKELY" IN HIS POCKET ADAPTOR. THE PATIENT WAS SCHEDULED TO SEE HIS HEALTHCARE PROVIDER (HCP) THE FOLLOWING DAY.
ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD EXPERIENCED A "SHOCKING" FEELING WITH STIMULATION PRESENT WHEN THE POCKET HAD BEEN MANIPULATED. IMPEDANCE MEASUREMENTS WERE RUN SEVERAL TIMES WHILE THE POCKET WAS BEING MANIPULATED, LEFT SIDE SYMPTOMS COULD BE REPLICATED WHEN THE POCKET WAS TOUCHED. AN ISSUE WITH EXTENSION OR POCKET ADAPTER WAS SUSPECTED. IT WAS ALSO REPORTED THAT THE EXTENSIONS WERE BEING CHANGED TOGETHER WITH THE POCKET ADAPTOR AT THE TIME OF THE REPORT. PER BATTERY LONGEVITY CALCULATIONS IT WAS DECIDED NOT TO REPLACE THE BATTERY. IT WAS INDICATED THAT THE REPORTER HAD BEEN "HAVING TROUBLE" WITH THE POCKET ADAPTOR. ELEVATED IMPEDANCE WAS NOTED BETWEEN C-7 (3482 OHMS). IT WAS ALSO THOUGHT THAT THERE MIGHT BE A SHORT CIRCUIT BUT IT WAS UNKNOWN WHICH ELECTRODE PAIR THAT INVOLVED, IF ANY. MORE THAN TWO WEEKS LATER IT WAS STATED THAT HE PATIENT HAD BEEN SEEN AND IT HAD BEEN DECIDED THAT SURGERY WAS NEEDED. THE DEVICE WAS CHANGED OUT AND NEW EXTENSIONS WERE RETUNNELED ON (B)(6) 2012. HOWEVER, NO EXPLANT DATE FOR THE DEVICE WAS AVAILABLE IN THE MANUFACTURER'S DATABASE, AND, AS PREVIOUSLY HAD BEEN STATED, LONGEVITY CALCULATIONS HAD INDICATED THAT NO BATTERY CHANGE HAD BEEN NEEDED AT THE TIME, SO IT WAS UNCLEAR IF THE BATTERY HAD BEEN REPLACED OR NOT. IT WAS INDICATED THAT THE PATIENT WAS STILL HAVING SOME IMPEDANCE ISSUES BUT "THAT HAD TO DO WITH THE LEADS" AND "THIS WAS BEING MANAGED." THE PATIENT "TOLERATED THE PROCEDURE FINE AND THERE WERE NO ISSUES." AT THIS POINT THE IMPEDANCES WERE BEING MONITORED AND THE PATIENT WAS UNDER OBSERVATION. IT WAS STATED THAT IF THERE WERE NO IMPROVEMENT, TAKING OTHER ACTIONS MIGHT BE NEEDED BUT AT THE MOMENT IT WAS NOT A CONCERN FOR THE PHYSICIAN.
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 | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Required Intervention |