SYNCHROMED II
Report
- Report Number
- 3004209178-2012-10564
- Event Type
- Injury
- Date Received
- November 20, 2012
- Report Date
- October 25, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
FINAL ANALYSIS OF THE PUMP FOUND MOISTURE, RESIDUE, AND CORROSION THROUGHOUT THE GEAR-TRAIN.
PRODUCT ID: 8832, SERIAL# (B)(4), IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN, PRODUCT TYPE: PROGRAMMER; PRODUCT ID: 8711, LOT# J10953R54, IMPLANTED: 2002 (B)(6), PRODUCT TYPE: CATHETER. (B)(4).
IT WAS REPORTED THAT THE PATIENT SYMPTOMS OF DIFFICULTY SLEEPING, FEELING ¿SCARED¿ AND ¿NERVOUS¿, WAS ¿LOST IN MY HEAD¿, BEING ¿VERY, VERY SICK OFF AND ON¿, ¿NOT GETTING THE [PAIN] RELIEF THAT I WAS LOOKING TO GET¿, ¿CAN¿T EVEN HARDLY GET UP WITHOUT WANTING TO THROW UP OR GO TO THE BATHROOM IN MY PANTS¿, AND ¿MY BODY IS JUST NOT THERE¿.
IT WAS REPORTED THAT PATIENT WAS REFILLED THREE WEEKS AGO AND ALL SEEMED WELL. LAST NIGHT, PATIENT WAS IN GREAT PAIN AND WENT TO THE ER. HE WAS TOLD THAT HIS MOTOR WAS STALLED, HIS PUMP WAS ALARMING. PER REPORTER "ER THOUGHT HE WAS OVERDOSING BECAUSE OF THE WAY HE WAS ACTING". HE WAS GIVEN FENTANYL IM AND EVENTUALLY AFTER 5 HOURS HE WAS ABLE TO WALK OUT THE DOOR. DRUGS DELIVERED VIA THE DEVICE WERE FENTANYL AND BUPIVACAINE. PATIENT VISITED HIS HEALTHCARE PROVIDER (HCP) THEREAFTER AND INDICATED THAT HIS PUMP ALARM WAS GOING OFF, AND HE WAS 3 WEEKS FROM HIS REFILL DATE. HCP CONFIRMED THAT THE MOTOR HAD STALLED AND WAS NOT ABLE TO RESTART IT. HE WAS ABLE TO RESET IT WITH THE CLINICIAN PROGRAMMER BUT WAS NOT SUCCESSFUL. HCP GAVE HIM A PRESCRIPTION FOR FENTANYL STICKS AND PATCHES, LOW DOSES. IT WAS FURTHER REPORTED THAT PATIENT HAD WITHDRAWAL, HAD BEEN "VERY SICK OFF AND ON" THE PAST MONTH AND THEY ASSUMED THIS WAS BECAUSE, THE PUMP HAD BEEN "KIND OF WORKING AND KIND OF NOT". PER THE REPORTER, PATIENT HAD SEEN THE HCP ON (B)(6) 2012 WHO CONFIRMED THE PUMP WAS "BROKEN "STALLED" AND DIDN'T THINK THAT THE PUMP WILL RESTART. THE FENTANYL SUB-LINGUAL SUCKERS WERE NOT HELPING THE PATIENT'S PAIN. THE PAIN LEVEL "IS THROUGH THE ROOF"; PATIENT DOESN'T WANT TO MOVE, THROWS UP AND DOES NOT WANT TO EAT; "BODY IS JUST NOT THERE". THE PUMP ALARM WAS HEARD A DAY OR TWO PRIOR (B)(6) 2012 AND WAS MISTAKEN TO BE THE MP3 PLAYER. THE ALARM WAS GETTING LOUDER AND OCCURRING MORE OFTEN. PATIENT HAD HAD AN UPPER AND LOWER CT SCAN OF ABDOMEN 3-4 WEEKS AGO AND THEN A WEEK LATER HAD A COLONOSCOPY. PATIENT WAS SCARED. PATIENT'S PTM (PERSONAL THERAPY MANAGER) SHOWED THE ERROR CODE 8476 I.E. MOTOR STALL. LATER ON INTERROGATING THE PUMP AGAIN IT WAS REPORTED THAT THE PUMP HAD ALARMED CRITICAL, CONFIRMED VIA TELEMETRY AND WAS DUE TO MOTOR STALL. THE STALL WAS CONSTANT AND HAD NOT RECOVERED. PATIENT HAD RETURN OF SYMPTOMS, ESPECIALLY INCREASED BASELINE PAIN, "LOTS OF PAIN". ON (B)(6) 2012, IT WAS REPORTED THAT PATIENT WAS "SEIZING". HCP WAS WORKING ON GETTING THE PATIENT'S PUMP REPLACED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
ADDITIONAL INFORMATION: IT WAS REPORTED THAT THAT THE PUMP WAS REPLACED ON (B)(6), 2012. THE MOTOR STALL HAD NOT RECOVERED.
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SINCE THE PATIENT'S PUMP REPLACEMENT, THE PATIENT HAD BEEN SEEN FOR A FOLLOW-UP AT HIS PHYSICIAN'S OFFICE AND WAS "DOING VERY WELL."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |