FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1924805
·
Received December 7, 2010
Report
- Report Number
- 3004209178-2010-10288
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- January 1, 2010
- Report Date
- December 6, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- 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
THE PT EXPERIENCED INFECTION. THE PUMP WAS EXPLANTED AND NOT REPLACED. THE PUMP DELIVERED MORPHINE AND BUPIVICAINE. THE PT WOULD NOT HAVE ANOTHER PUMP IMPLANTED. PER THE REPORTER, THE PT'S "RECOVERY" WAS NOT POSSIBLE DUE TO CANCER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other | PROGRAMMER: MODEL 8835, LOT# NPG018633N| CATHETER: MODEL 8709SC, LOT# N259884004| EXPLANTED:| IMPLANTED: |