FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1823486
·
Received August 25, 2010
Report
- Report Number
- 3004209178-2010-06410
- Event Type
- Injury
- Date Received
- August 25, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 27, 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).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT EXPERIENCED VIOLENT EPISODES OF THE FOLLOWING SYMPTOMS: HEART RATE WAS NOTED TO HAVE BEEN 170 BEATS PER MINUTE INTERMITTENTLY FOR 30 MINUTES AT A TIME, AND THE PATIENT WAS SWEATING. THE PATIENT WENT IN FOR A CATHETER STUDY. A DYE STUDY WAS ATTEMPTED, HOWEVER THE PHYSICIAN COULD NOT ASPIRATE FROM THE END OF THE CATHETER. A DECISION WAS MADE TO ABORT THE PROCEDURE DUE TO A PROBLEM WITH THE CATHETER. THE DRUG BEING ADMINISTERED BY THE PUMP WAS LIORESAL (2000 MCG/ML; AT 329.6 MCG/DAY). THE PATIENT HAD STABILIZED, AND WAS TAKING ORAL BACLOFEN. A POSSIBLE CATHETER REVISION WAS DISCUSSED.
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 | 16 YR | Other | IMPLANTED:| CATHETER: MODEL 8709, LOT# J12364R28| EXPLANTED: |