FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1902235
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09507
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SLIGHT WEAKNESS ON THE PATIENT'S RIGHT SIDE, FOR THE PREVIOUS "COUPLE OF MONTHS." A CT MYELOGRAM WAS PERFORMED AND CONFIRMED THE PRESENCE OF A GRANULOMA. THE PATIENT'S DEVICE WAS SCHEDULED FOR EXPLANTATION ON (B)(6) 2010. THE PATIENT'S PUMP CONTAINED DILAUDID, BUPIVACAINE, AND CLONIDINE. THERE WAS NO INFORMATION PROVIDED REGARDING THE CONCENTRATION OR DOSAGES OF THE MEDICATIONS USED IN THE PATIENT'S PUMP. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION 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 | 63 YR | Required Intervention | EXPLANTED:| CATHETER: MODEL 8709, LOT# N067718021| IMPLANTED: |