FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1902236
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09481
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- October 1, 2010
- Report Date
- November 8, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP AND CATHETER WERE REMOVED ON (B)(6) 2010 DUE TO INFECTION. PER PHYSICIAN REPORT, "THE POCKET INCISION HAD A HUGE BLISTER WITH PUS POCKET FORMATION SO IT WAS DECIDED TO EXPLANT THE ENTIRE SYSTEM". THE PT WAS ON LIORESAL 2000 MCG/ML AT A DOSE OF 600 MCG/DAY. THE PT WAS STARTED ON ORAL BACLOFEN 20 MG THREE TIMES A DAY PRIOR TO EXPLANT. HE WAS HOSPITALIZED AT THE TIME OF THE REPORT FOR IV ANTIBIOTICS ADMINISTRATION. PER THE HCP, THEY WILL MOST PROBABLY REPLACE THE PUMP AND CATHETER AT A LATER DATE. THE FACILITY DISPOSED OF THE PUMP AND CATHETER. 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 | 31 YR | Hospitalization| R | EXPLANTED:| CATHETER: MODEL 8709, LOT # N175499010| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8596SC, LOT # N178306023| IMPLANTED: |