FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1923235
·
Received November 9, 2010
Report
- Report Number
- 3004209178-2010-09150
- Event Type
- Malfunction
- Date Received
- November 9, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 20, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER AN MRI THE PT HAD A BURN THAT "LOOKED LIKE A SUNBURN" ON THE ARM THAT WAS ON THE SIDE OPPOSITE THE PUMP. THE PUMP WAS CHECKED POST- MRI AND APPEARED TO BE FUNCTIONING NORMALLY. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U 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 | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | CATHETER: MODEL 8596SC, LOT# N237043003| EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8598A, LOT# N257276012| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG018359N| CATHETER: MODEL CATHETER, LOT# UNK| IMPLANTED: |