FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2191077
·
Received July 29, 2011
Report
- Report Number
- 3004209178-2011-05869
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- March 25, 2010
- Report Date
- December 11, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S PUMP MEDICATION DAILY RATE WAS INCREASED ON (B)(6) 2010. NO INFORMATION WAS PROVIDED AS TO WHAT DRUG WAS CONTAINED IN THE PUMP OR THE DOSAGE. THE PUMP WAS INTERROGATED ON (B)(6) 2010, AND THERE WERE NO ALERTS FOUND OR INDICATIONS THAT THE PUMP HAD MALFUNCTIONED.
Description of Event or Problem · 1
A PT HAD A LOSS OF THERAPEUTIC RELIEF/INCREASED PAIN. THE CATHETER WAS REPOSITIONED AT THE C3 LOCATION ON (B)(6) 2010. THE TIP OF THE PREVIOUSLY EXISTING CATHETER WAS TIED OFF DUE TO POSSIBLE INVOLVEMENT REGARDING A TUMOR. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2010. ADD'L INFO WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Required Intervention | IMPLANTED:| PROGRAMMER: MODEL 8832, LOT# NJG004132N| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N126720005| IMPLANTED: |