FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1915159
·
Received December 1, 2010
Report
- Report Number
- 3004209178-2010-10069
- Event Type
- Injury
- Date Received
- December 1, 2010
- Report Date
- November 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004/S56
- Adverse Event
- 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
THE PT EXPERIENCED AN UNDERDOSE. SPECIFIC SYMPTOMS OF UNDERDOSE WERE NOT REPORTED. TROUBLESHOOTING OPTIONS FOR THE PUMP WERE BEING CONSIDERED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | Other | CATHETER: MODEL 8731, LOT# B002400N01| EXPLANTED:| IMPLANTED: |