FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3120620
·
Received May 20, 2013
Report
- Report Number
- 3004209178-2013-07916
- Event Type
- Injury
- Date Received
- May 20, 2013
- Report Date
- April 21, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PPRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OVERDOSE OCCURRED HOWEVER, THE SPECIFIC SYMPTOMS WERE NOT AVAILABLE. THE HEALTH CARE PROVIDER (HCP) SUSPECTED AND OVERDOSE OF A POLYSUBSTANCE, POSSIBLY HEROIN. INFORMATION WAS REVIEWED REGARDING STOPPED PUMP MODE. IT WAS FURTHER VERIFIED THAT THE PUMP WAS IN STOPPED PUMP MODE. LASTLY, IT WAS REPORTED THAT THE PATIENT HAD OVERDOSED ON STREET DRUGS AND THERE WAS NOTHING WRONG WITH THE PUMP. THE PUMP WAS TURNED OFF RELATED TO THE OVERDOSE. THIS DEVICE SYSTEM DELIVERED DILAUDID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221422 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |