FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1061426
·
Received June 17, 2008
Report
- Report Number
- 3004209178-2008-03296
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 1, 2007
- Report Date
- June 10, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- PENDING
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SERIAL NUMBER OF THE DEVICE IS INCLUDED IN THE SYNCHROMED II MISSING PROPELLANT RECALL AND PHYSICIAN COMMUNICATION DATED 05/21/08.
Description of Event or Problem · 1
THE HCP EXPERIENCED PROBLEMS WITH PUMP ASPIRATION AND REFILL. THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. INITIALLY, THE CATHETER WAS REPLACED, WITHOUT ANY SUCCESS. THEN THE PUMP WAS EXPLANTED AND REPLACED. SINCE THE PUMP REPLACEMENT, THE PT STATUS WAS REPORTED AS "GOOD". THERE WAS NO PT INJURY. THE PUMP WAS USED TO DELIVER MORPHINE AND CLONIDINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |