FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2180975
·
Received July 22, 2011
Report
- Report Number
- 3004209178-2011-05667
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- August 17, 2010
- Report Date
- June 30, 2011
- 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
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PATIENT RECOVERED WITHOUT SEQUELA. PUMP WAS ALSO DELIVERING MORPHINE.
Description of Event or Problem · 1
THE PT EXPERIENCED POOR PAIN CONTROL; THE PT HAD PAIN ALL OVER HER BODY. THE PT WAS HOSPITALIZED. IN (B)(6) 2011, THE CATHETER WAS REPLACED AND THE PUMP SITE WAS REVISED; IT WAS UNCLEAR IF ONE OR TWO PROCEDURES WERE PERFORMED. THE PT OUTCOME WAS REPORTED AS "ONGOING EVENT". THE DEVICE WAS USED TO INFUSE LIORESAL 1000 MCG/ML AT 236.1 MCG/DAY. 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 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R | EXPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N134586| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N134229001| IMPLANTED: |