FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4210433
·
Received October 29, 2014
Report
- Report Number
- 3004209178-2014-20595
- Event Type
- Injury
- Date Received
- October 29, 2014
- Report Date
- October 6, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1570-2014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT TWICE A WEEK, THE PATIENT FELT ¿REALLY SLEEPY¿ AFTER BEING CHECKED WITH A SECURITY WAND. THE PATIENT FELT AS IF HE WAS GETTING A BOLUS OF MEDICATION EACH TIME. THE PATIENT ALSO EXPERIENCED SEVERE NAUSEA,VOMITING, AND VERTIGO. THE CAUSE OF THE ISSUE WAS NOT DETERMINED. UPON INTERROGATION OF THE PUMP, NO FAULTS WERE NOTED. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP WAS USED TO DELIVER PRIALT AND DILAUDID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692497 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00036 YR | Other |