FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2152318
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04716
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 27, 2011
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT THOUGHT THAT HIS PUMP HAD "STOPPED". THE PT REPORTED WITH WITHDRAWAL SYMPTOMS. NO INFO REGARDING THE DRUG, DOSAGE/CONCENTRATION WAS AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, 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 | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CATHETER: MODEL 8578, LOT# N212922002| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG019271N| CATHETER: MODEL 8703W, LOT# L49374| IMPLANTED:| EXPLANTED: |