FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1132592
·
Received August 22, 2008
Report
- Report Number
- 3004209178-2008-05161
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 9, 2008
- Report Date
- July 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED CONSTANT DIARRHEA, VOMITING, FEVER AND HIGH BLOOD PRESSURE SINCE REPLACEMENT OF HER PUMP. SHE HAS EXPERIENCED THE SAME SYMPTOMS WITH THE "OLD PUMP", BUT THE SYMPTOMS WERE INTERMITTENT AND DID NOT LAST LONG. THE DRUG IN THE PUMP WAS MORPHINE. THE CONCENTRATION AND DOSE WERE NOT REPORTED. NO OUTCOME REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL 8711| EXPLANTED| PROGRAMMER MODEL 8840| IMPLANTED |