FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1934497
·
Received November 23, 2010
Report
- Report Number
- 3004209178-2010-09890
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 17, 2010
- 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
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT NEVER HAD THERAPEUTIC EFFECT. THE PT WAS EXPERIENCING PAIN THAT HE HAD NOT HAD PRIOR TO IMPLANT. A DYE STUDY WAS DONE FOLLOWING IMPLANT AND THE CATHETER WAS FOUND TO BE BLOCKED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N244438010| IMPLANTED: |