FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2011488
·
Received March 7, 2011
Report
- Report Number
- 3004209178-2011-01696
- Event Type
- Injury
- Date Received
- March 7, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 16, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - UNABLE TO EAT FOR ONE WEEK.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS ONE WEEK PRIOR TO REFILL. THE PUMP WAS REFILLED ONE WEEK AGO AND HAD STILL NOT YET RECOVERED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS NOT ABLE TO EAT FOR ONE WEEK. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 | Hospitalization | EXPLANTED:| CATHETER: MODEL 8709, LOT# J0058154R| IMPLANTED: |