FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1943916
·
Received December 28, 2010
Report
- Report Number
- 3004209178-2010-10803
- Event Type
- Injury
- Date Received
- December 28, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 29, 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
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HCP BELIEVED THAT THE PT HAD A GRANULOMA AT THE CATHETER SITE; ALSO, THERE MAY BE A CATHETER DISCONNECT. THE PT PREVIOUSLY HAD HYDROMORPHONE IN THE PUMP; SALINE WAS IN THE PUMP AT THE TIME OF THE REPORT. A CATHETER REVISION WAS BEING PLANNED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | PROGRAMMER: MODEL 8840, LOT #: UNKNOWN| IMPLANTED:| CATHETER: MODEL 8709, LOT #: N080736004| EXPLANTED: |