FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2130548
·
Received June 14, 2011
Report
- Report Number
- 3004209178-2011-04397
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 17, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- 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
IT WAS REPORTED THAT THE PATIENT'S CATHETER WAS REVISED ON (B)(6) 2011 (REMOVED COMPLETELY AND A NEW ONE WAS PLACED) DUE TO AN OCCLUSION AND A HOLE. THE COMPLICATION REPORTED WAS THAT THERE WAS CATHETER BLOCKAGE. THE EVENT WAS CONFIRMED. THERE WAS ALSO A MICRO-TEAR IN THE CATHETER. THE MICRO-TEAR WAS CONFIRMED. THE PATIENT HAD INCREASED BASELINE PAIN. THE PATIENT'S PUMP WAS INTACT WITH THE DRUG. PRIMING INCLUDED THE CATHETER VOLUME ONLY. THE PATIENT WAS DOING GREAT. THE DRUGS IN THE PUMP AT THE TIME OF THE EVENT WERE HYDROMORPHONE, CLONIDINE, BUPIVICAINE, AND COMPOUNDED BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | CATHETER: MODEL 8709SC, LOT# N127295008| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11169R50 |