FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1892213
·
Received November 2, 2010
Report
- Report Number
- 3004209178-2010-08782
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- July 1, 2010
- Report Date
- October 8, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P960004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PUMP AND CATHETER HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD THEIR PUMP DEVICE REMOVED DUE TO AN INFECTION IN THE PUMP POCKET. SKIN EROSION AND REDNESS AT THE POCKET SITE WERE REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. THE PT RECOVERED WITHOUT SEQUELA.
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 | 17 YR | Required Intervention | CATHETER: MODEL 8711, LOT# J11313R07| IMPLANTED:| EXPLANTED: |