FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1842087
·
Received September 20, 2010
Report
- Report Number
- 3004209178-2010-07102
- Event Type
- Injury
- Date Received
- September 20, 2010
- Date of Event
- August 18, 2010
- Report Date
- August 18, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ACCUMULATION OF FLUID IN POCKET. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
THE PT EXPERIENCED SIGNS AND SYMPTOMS OF WITHDRAWAL, RETURN OF PAIN, HEADACHE AND ACCUMULATION OF FLUID IN THE PUMP POCKET SITE. THE PUMP DELIVERED DILAUDID 2 MG/ML AT 0.18 MG/DAY. THE CATHETER SEGMENT WAS EXPLANTED AND REPLACED ON (B)(6) 2010. THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 57 YR | Required Intervention | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11568R22| PROGRAMMER: MODEL 8835, LOT# NGP013356N |