FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2191095
·
Received July 29, 2011
Report
- Report Number
- 3004209178-2011-05896
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 11, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1151-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
SUPPLEMENTAL SUBMITTED TO UPDATE/CORRECT CONCLUSION CODES. ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD PNEUMONIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A GRANULOMA, WHICH WAS REMOVED. CURRENTLY, THE PUMP "STICKS OUT QUITE A BIT". A SURGERY FOR EITHER REPOSITIONING OR TO MAKE A DEEPER POCKET WAS BEING CONSIDERED. PT BELIEVED HER PUMP WAS IMPLANTED IN (B)(6) 2011. THE PT HAD ALSO MISSED A REFILL. NO SYMPTOMS WERE REPORTED RELATED TO THE MISSED REFILL, WHICH WAS RE-SCHEDULED FOR (B)(6) 2011. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR | Required Intervention | CATHETER: MODEL 8731SC, LOT# N234459009| EXPLANTED:| IMPLANTED: |