SYNCHROMED II
Report
- Report Number
- 3007566237-2011-07846
- Event Type
- Injury
- Date Received
- September 14, 2011
- Date of Event
- September 29, 2010
- Report Date
- September 20, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
FINAL ANALYSIS OF THE PUMP REVEALED NO ANOMALY, NORMAL DEVICE FUNCTION. ONLY THE PUMP CONNECTOR WITH THE PROXIMAL CATHETER SEGMENT WAS RETURNED FOR ANALYSIS. THE SEGMENT WAS PARTIALLY OCCULDED WITH DRIED DRUG OR BLOOD.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS INITIALLY REPORTED THAT AN ALARM WAS HEARD AND ALSO CONFIRMED BY TELEMETRY. IT WAS DUE TO ZERO ML RESERVOIR VOLUME. HCP (HEALTH CARE PROFESSIONAL) THOUGHT THE REFILL DATE WAS (B)(6) 2010, BUT THE LOW RESERVOIR ALARM SOUNDED ON (B)(6) 2010. PT WAS LAST REFILLED ON (B)(6) 2010. DOSE WAS INCREASED ON (B)(6) 2010, BUT THEY COULD NOT FIND THE SESSION FILES FROM EITHER UPDATE TO SEE EXACTLY WHAT THE REFILL DATE WAS FOR THOSE SESSIONS. THE (B)(6) 2011 DATE WAS WRITTEN IN THE PT'S CHART. HCP MAY NOT HAVE ADJUSTED THE REFILL DATE BASED ON THE DOSE INCREASE PROGRAMMED (B)(6) 2011, BUT IT COULD NOT BE CONFIRMED SINCE NO SESSION FILES WERE AVAILABLE. HCP WAS MOST LIKELY TO FILL THE PUMP TO SEE IF IT'S STILL FUNCTIONAL. BASED ON EMPTY RESERVOIR ALARM, THE PUMP HAD BEEN DRY FOR ROUGHLY 15 DAYS. DRUGS DELIVERED VIA THE PUMP WERE MORPHINE 20MG/ML AND BUPIVACAINE 20MG/ML 4.5MG/DAY. ON (B)(6) 2010, PT HAD CALLED THE DOCTOR'S OFFICE COMPLAINING OF HIS PUMP ALARMING. HE HAD BEEN ADMITTED TO THE HOSPITAL OVER THE WEEKEND, BUT DID NOT KNOW WHY HE HAD BEEN ADMITTED. ON PUMP INTERROGATION A "LOW RESERVOIR ALARM" ON (B)(6) 2010 AND AN "EMPTY RESERVOIR ALARM" ON (B)(6) 2010 WAS NOTED. THE PUMP ALSO SHOWED THAT IT SHOULD HAVE ALARMED FOR A LOW RESERVOIR ON (B)(6) 2010, WHEN PT WAS SCHEDULED FOR A PUMP REFILL. PT HAD NOTICED THE ALARM ON THURSDAY OF LAST WEEK AND WAS IN SO MUCH PAIN THAT HE CONSIDERED TAKING HIS OWN LIFE "BY PUTTING A SHOTGUN IN MY MOUTH". PT HAD VISITED THE ED ON FRIDAY. IT WAS STATED THAT NO ONE COULD READ HIS PUMP AND THAT THE PROGRAMMERS WERE "LOCKED UP UNTIL MONDAY." THE PHYSICIAN WAS NOTIFIED OF THE PUMP STATUS AND UPON REVIEW OF THE EMR AND SCHEDULE, IT WAS FOUND THAT PT HAD CANCELLED HIS PUMP REFILL APPOINTMENT ON (B)(6) 2010 AND REFUSED TO RESCHEDULE. HE WAS DISCHARGED FROM ED AND SENT TO DOCTOR'S OFFICE FOR HIS PUMP TO BE REFILLED. PHYSICIAN OPTED TO REFILL THE PT'S PUMP REDUCING THE DOSE TO 1MG/DAY AND PLANNED TO RECHECK THE RESERVOIR VOLUME IN ONE WEEK TO NOTE IF THE VOLUME HAD CHANGED. ON (B)(6) 2011, PT DESIRED THAT HE WANTED HIS PUMP TURNED OFF AND EXPLANTED AS SOON AS POSSIBLE. PT WAS SCHEDULED FOR A PUMP EXPLANTED ON (B)(6) 2011. IT WAS LATER NOTED THAT PT MISSED HIS CARDIAC CLEARANCE APPOINTMENT AND THE PUMP WAS EXPLANTED THE NEXT DAY.
IT WAS LATER REPORTED THAT THE PATIENT HAD REQUESTED HIS PUMP BE REMOVED BECAUSE IT "RUBBED ON HIS RIBS" AND MADE IT HARD FOR HIM TO BREATHE. THE PATIENT HAD SEVERE LORDOSIS AND WALKED VERY BENT OVER AIDED WITH A WALKER. THE PUMP INFUSION RATE WAS DECREASED GRADUALLY TO MINIMUM RATE AND THEN EXPLANTED. THE PUMP WAS EXPLANTED (B)(6) 2011. PER THE REPORTER, THE PATIENT RECOVERED WITHOUT SEQUELA. THE MEDICATION THAT WAS ADMINISTERED VIA THE PUMP PRIOR TO EXPLANTATION WAS MORPHINE 20 MG/ML CONCENTRATION AT THE MINIMUM DAILY RATE AND BUPIVACAINE 20 MG/ML CONCENTRATION AT THE MINIMUM DAILY RATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | EXPLANTED:| (B)(4)| CATHETER: MODEL 8731, LOT# N062281034| IMPLANTED: |