FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 3122875
·
Received May 21, 2013
Report
- Report Number
- 3004209178-2013-08010
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 25, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-0591-2009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
THE PATIENT HAD AN MRI ON (B)(6) 2013. THE MOTOR STALL RECOVERY DID NOT OCCUR. A MOTOR STALL DUE TO MRI EXPOSURE WAS REPORTED. IT WAS FURTHER NOTED THAT IT WAS A FALSE MOTOR STALL DUE TO TELEMETRY STATE. THIS WAS NOTED AT A REFILL APPOINTMENT ON (B)(6) 2013. THE PATIENT HAD WITHDRAWAL SYMPTOMS, BUT THE CORRECT AMOUNT OF RESIDUAL FLUID WAS RECORDED AND ASPIRATED. THE PATIENT WAS NOTED TO BE ALIVE AND WITHOUT INJURY. THE PATIENT WAS REPROGRAMMED AS A RESULT OF THE EVENT. TELEMETRY WAS NOTED TO BE APPROPRIATE AFTER PROGRAMMING. THE MEDICATION USED WITHIN THE SYSTEM WAS DILAUDID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223884 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR |