FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3870694
·
Received June 12, 2014
Report
- Report Number
- 3004209178-2014-11522
- Event Type
- Malfunction
- Date Received
- June 12, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 23, 2014
- 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
- NE, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, LOT# N146292005, IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS ALARMING SO IT WAS REFILLED. THE PATIENT WAS DOING WELL AND REPORTEDLY RECOVERED WITHOUT PERMANENT IMPAIRMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A CRITICAL ALARM FOR EMPTY PUMP WAS SOUNDING AND CONFIRMED BY TELEMETRY. IT WAS NOTED THAT THERE WAS A MISSED REFILL. THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT OF INCREASED SPASMS FOR THE PAST TWO DAYS. THE REPORTER DID NOT THINK THAT THE PATIENT HEARD THE PUMP ALARMS AND STATED THAT THE PATIENT WAS "NOT REAL RELIABLE". THE PUMP WAS INFUSING GABLOFEN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348336 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00037 YR |