FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1902198
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09524
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- 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 PATIENT HAD AN ALLERGIC REACTION WITH LIP SWELLING AND RESPIRATORY DISTRESS. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM. THE HEALTH CARE PROFESSIONAL PLANNED TO STOP THE PUMP. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS DILAUDID. 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 | 45 YR | Other | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# B005780N61| PROGRAMMER: MODEL 8835, LOT# NPG019298N| IMPLANTED:| EXPLANTED: |