FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1980007
·
Received January 24, 2011
Report
- Report Number
- 3004209178-2011-00561
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 18, 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
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A CHANGE IN THERAPY EFFECT FOLLOWING A REFILL SESSION: FOR THE PAST "COUPLE DAYS" THE PT COULD NOT GET OUT OF BED AND EXPERIENCED NAUSEA AND SEVERE BACK PAIN. DURING PUMP REFILL PROCEDURES THE PUMP USUALLY HAD 4 CC, BUT "THIS TIME READ 16 CC." THE PT PLANNED TO VISIT THE HCP (HEALTHCARE PROFESSIONAL) IF SYMPTOMS WORSENED. THE PUMP MEDICATION WAS NO REPORTED. ADDITIONAL INFORMATION 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 | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | IMPLANTED:| EXPLANTED:| LOT# NGF035064R| CATHETER: MODEL 8711, LOT# J11404R69| IMPLANTABLE INFUSION PUMP: MODEL 8627-18| EXPLANTED:| CATHETER: MODEL 8711, LOT# J11406R40| IMPLANTED:| EXPLANTED:| IMPLANTED: |