FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2427637
·
Received January 25, 2012
Report
- Report Number
- 3004209178-2012-00489
- Event Type
- Malfunction
- Date Received
- January 25, 2012
- Report Date
- January 3, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CATHETER MODEL: 8709SC, (B)(4), IMPLANTED: (B)(6), EXPLANTED: UNK; CATHETER REV KIT PROX SEG MODEL: 8596SC, (B)(4), IMPLANTED: (B)(6), EXPLANTED: UNK; APPLICATION SOFTWARE MODEL: 8870, SERIAL #: UNK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) PERFORMED TELEMETRY TWICE AND RECEIVED "(B)(4) INVALID ERI?? MONTHS". THE PUMP WAS UPDATED AND THAT WAS SUCCESSFUL. HCP MADE CHANGES THEN TO RESERVOIR VOLUME AND DOSE PER DAY AND UPDATED PUMP AGAIN. PATIENT DIDN'T HEAR ALARMS AND WAS NOT GOING THRU WITHDRAWALS. UNSURE IF EMI (ELECTROMAGNETIC INTERFERENCE) INTERFERED WHILE PERFORMING INITIAL TELEMETRY. PUMP MEMORY ERROR WAS INDICATED, THE PUMP LOGS WERE NORMAL. DRUG DELIVERED VIA THE DEVICE WAS LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |