FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1834576
·
Received September 9, 2010
Report
- Report Number
- 3004209178-2010-06889
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 11, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY WITH A PUMP WITH THE ACTUAL RESIDUAL VOLUME (ARV) OF 10 ML GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV) OF 0 ML. THE PATIENT REPORTED BEING IN WITHDRAWAL WITH NO SPECIFIC SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11483R34| CATHETER: MODEL 8709, LOT# J12436R28| CATHETER: MODEL 8578, LOT# N244254015| IMPLANTED: |