FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1783908
·
Received July 30, 2010
Report
- Report Number
- 3004209178-2010-05827
- Event Type
- Malfunction
- Date Received
- July 30, 2010
- Date of Event
- December 17, 2008
- Report Date
- July 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
PT CODE: 1802 - NOT LABELED.
Description of Event or Problem · 0
IT WAS LATER REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2010 DUE TO BRAIN CANCER. THERE WERE NO PUMP ISSUES REPORTED. THE PATIENT RECEIVED DILAUDID 50 MG/ML; DAILY DOSE NOT REPORTED. WHEN THE PATIENT WOULD HAVE CONCERNS ABOUT IT, THE HCP WOULD LOOK AT THE PRINT OUTS, BUT THEY ALWAYS CONFIRMED THAT THE PUMP WAS WORKING FINE. NO FURTHER ACTIONS WERE REQUIRED FOR THE PUMP.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY PT THAT THE LAST TWO PUMPS HAD FAILED. PLEASE REFER TO MFR REPORT(S) #6000030-2005-00875, 3007566237-2010-05828.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 581286 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | CATHETER: MODEL 8709, LOT #J11401R49, IMPLANTED:| EXPLANTED:| EXPLANTED: | IMPLANTABLE INFUSION PUMP: MODEL 8637-20, LOT #NGP324581H, IMPLANTED: |