FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2231116
·
Received August 26, 2011
Report
- Report Number
- 3004209178-2011-06964
- Event Type
- Injury
- Date Received
- August 26, 2011
- Report Date
- August 15, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A FLIPPED PUMP WAS REPORTED. PT HAD NO SYMPTOMS, BUT "WAS NOT GETTING DRUG OR WAS GETTING LESS DRUG". IT WAS REPORTED THAT THE POCKET WAS REVISED ON (B)(6) 2011 "BECAUSE THE PUMP WAS VERY MOBILE IN THE POCKET". THE PUMP WAS SECURED. WHEN THE SURGEON OPENED THE POCKET, THE CATHETER THAT WAS BEHIND THE PUMP WAS TWISTED BUT NOT OCCLUDED. PHYSICIAN TRIMMED 11.5 CM FROM PUMP PORTION AND ADDED NEW CATHETER AND TRIMMED 1 CM FROM SPINAL PORTION. THE DRUG DELIVERED WAS BACLOFEN 249.8 MCG/DAY.
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 | Required Intervention | CATHETER: MODEL 8578, LOT# N280928002| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N285851003| IMPLANTED:| IMPLANTED: |