FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1910634
·
Received November 19, 2010
Report
- Report Number
- 3004209178-2010-09794
- Event Type
- Injury
- Date Received
- November 19, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 15, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED PAIN. IT WAS NOTED THAT THE PT RESIDED IN A NURSING HOME AND DOES NOT SPEAK. HE COMMUNICATES HIS PAIN THROUGH AGITATION AND SCREAMS OF PAIN. THE DOSAGE HAD BEEN TITRATED ABOUT 2 WEEKS PRIOR. IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO A SKIN INFECTION. NO FURTHER INFORMATION WAS PROVIDED. THE PUMP WAS USED TO DELIVER LIORESAL.
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 | 62 YR | Required Intervention | CATHETER: MODEL 8709SC, LOT# N247722002| IMPLANTED:| EXPLANTED: |