FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 4243618
·
Received November 11, 2014
Report
- Report Number
- 3004209178-2014-21325
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Report Date
- October 20, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 8709SC, SERIAL# N158647001, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD MORE MEDICATION THAN EXPECTED OVER THE PAST SIX MONTHS AT REFILLS. IT WAS NOTED THE HEALTHCARE PROVIDER (HCP) WAS SURPRISED AT THE LAST REFILL AT THE AMOUNT OF DRUG LEFT IN THE PUMP. THE PUMP WAS BEING USED TO DELIVER DILAUDID AND ZICONOTIDE. PATIENT SYMPTOMS, INTERVENTIONS, THE CAUSE OF THE EVENT, SPECIFIC DRUG VOLUMES, AND PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 726981 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR |