FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1840780
·
Received September 17, 2010
Report
- Report Number
- 3004209178-2010-07081
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- January 1, 2010
- Report Date
- August 19, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD AN INFECTION. IN ADDITION, IT WAS NOTED THAT THE PATIENT WAS SWEATING PROFUSELY, AND HAD FELT LIKE THEY WERE FREEZING AT THE SAME TIME. THE PATIENT HAD NAUSEA, AND THE PATIENT NOTED THAT WHEN HE VOMITED, IT TASTED LIKE "SALT WATER". THE SYMPTOMS OCCURRED DURING A NORMAL REFILL CYCLE, AND WERE NOT EXPERIENCED BEFORE. IT WAS INDICATED THAT THE PATIENT'S PUMP WAS FILLED WITH SALINE IN (B)(6) 2008, AND THE "SALINE HAD NEVER BEEN REPLACED." THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | CATHETER: MODEL 8709, LOT #N167637025| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT #NPG010537N| EXPLANTED:| CATHETER: MODEL 8578, LOT #N157725| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: |