FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1913553
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09432
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- November 5, 2010
- Report Date
- November 5, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A SIGNIFICANT VOLUME DISCREPANCY WAS NOTED AT THE PT'S PUMP REFILL SESSION. THE EXPECTED RESIDUAL VOLUME WAS 30.6ML AND THE ACTUAL RESIDUAL VOLUME 8ML. THEY HAD PLANNED TO ADD 10ML TO THE PUMP UNTIL THEY WERE ABLE TO DO SOME TROUBLESHOOTING AND DETERMINE WHAT MIGHT BE GOING ON. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS MORPHINE. 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 | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N170801035| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG010535N| CATHETER: MODEL 8578, LOT# N172374008| IMPLANTED: |