FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1926035
·
Received November 10, 2010
Report
- Report Number
- 3004209178-2010-09224
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER DISCONNECTED FROM THE PUMP. DURING A DYE STUDY (B)(4) OF CLEAR FLUID WAS ASPIRATED. WHEN THE DYE WAS INJECTED, IT POOLED AROUND THE PUMP. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | CATHETER: MODEL 8709SC, LOT # N258388003| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT # NPG018236N |