FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2120159
·
Received June 6, 2011
Report
- Report Number
- 3004209178-2011-03991
- Event Type
- Injury
- Date Received
- June 6, 2011
- Report Date
- May 6, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1150-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REMOVED DUE TO A DEPLETED BATTERY. THE CATHETER WAS REPLACED "WHERE SOME GRANULOMAS WERE FOUND." NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT PROVIDED. 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER: MODEL 8709SC, LOT# N125198017| EXPLANTED:| IMPLANTED: |