FDA Adverse Event
Injury
Summary report: N
SYNDROMED II
MDR report key: 1090744
·
Received August 1, 2008
Report
- Report Number
- 3004209178-2008-04598
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 1, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PATIENT HAD A PUMP REPLACEMENT IN 2008, DUE TO NORMAL BATTERY DEPLETION. DURING THE PROCEDURE, THE PROXIMAL END OF THE CATHETER WAS FOUND TO BE BURIED IN SCAR TISSUE. A SUTURELESS CONNECTOR WAS ATTACHED TO THE END OF THE CATHETER AND CONNECTED TO THE PUMP. NO PRIMING BOLUS WAS GIVEN. THE MEDICATION WAS PROGRAMMED TO THE SAME RATE AS PRIOR TO THE REPLACEMENT. THE PUMP WAS USED TO DELIVER MORPHINE AND BACLOFEN. AT MIDNIGHT, AFTER THE REPLACEMENT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DROWSINESS. NO ADDITIONAL PROCEDURES WERE DONE. THE PATIENT WAS DISCHARGED THE NEXT DAY IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNDROMED II | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R | IMPLANTED:| CATHETER MODEL 8711 LOT# J10947R34| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK |