FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 3200267
·
Received July 1, 2013
Report
- Report Number
- 3004209178-2013-04604
- Event Type
- Death
- Date Received
- July 1, 2013
- Report Date
- July 15, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ERROR MESSAGE RECEIVED DURING INTERROGATION. THE MOTOR STALL OCCURRED AND THE PATIENT HAD PUMP REPLACEMENT. THE PATIENT WAS DOING WELL AFTER REVISION. THE PATIENT EXPIRED IN (B)(6) 2010, AND THE EXACT DATE OF DEATH WAS UNKNOWN. THE HEALTH CARE PROVIDER DIDN¿T BELIEVE TO BE PUMP RELATED. IT WAS REPORTED THAT RESPIRATORY FAILURE AND HEART DISEASE WERE CONTRIBUTING FACTORS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298408 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR | Death| R |