FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED EL
MDR report key: 1890242
·
Received October 22, 2010
Report
- Report Number
- 6000030-2010-08315
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- January 1, 2010
- Report Date
- September 27, 2010
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PT EXPERIENCED INTERMITTENT ANXIETY SPELLS. A PHYSICIAN WANTED TO RULE OUT A GRANULOMA, OR A CATHETER ISSUE. THE PHYSICIAN WAS UNSUCCESSFUL AT ATTEMPTING TO ACCESS/ASPIRATE THE CATHETER ACCESS PORT IN REGARDS TO TROUBLESHOOTING THE CATHETER. THE PT'S OUTCOME WAS NOT REPORTED. NO PUMP VOLUME DISCREPANCIES WERE NOTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | RICE CREEK MANUFACTURING | 8627-18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | CATHETER: MODEL 8709, LOT #: J11395R61| IMPLANTED:| EXPLANTED: |