FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1926221
·
Received November 10, 2010
Report
- Report Number
- 3004209178-2010-09233
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 1, 2010
- Report Date
- November 30, 2016
- 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
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED PT INDICATED RETURN OF SYMPTOMS. THE PT INDICATED SHE HAD BEEN IN PAIN SINCE FRIDAY. PT STATED SHE HAD DILAUDID IN PUMP. THE PT THOUGHT HER PUMP WAS CLOGGED BECAUSE LAST MONTH THE SAME THING HAPPENED BUT IT WENT AWAY AFTER A FEW DAYS. PT DID NOT TELL HER HCP OF THE LAST INCIDENT. PT HAD CONTACTED HER HCP, BUT HAD NOT HEARD BACK YET. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6) 2016. IT WAS REPORTED THAT THE CATHETER HAD A KINK, AND THE PATIENT WAS TOLD IT HAD CRYSTALLIZED. THE ISSUE WAS REPORTED TO BE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | CATHETER: MODEL 8578, LOT # N131626| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: |