FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1936121
·
Received December 13, 2010
Report
- Report Number
- 3004209178-2010-10408
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- January 1, 2010
- Report Date
- December 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A SURGICAL REVISION WAS PERFORMED (B)(6) 2010. PT SYMPTOMS OR DEVICE ISSUES THAT LED TO THE REVISION SURGERY WERE NOT REPORTED. THE PUMP WAS REPLACED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT # 3004209178201010406 FOR INFO REGARDING EVENT/PT OUTCOME FOLLOWING (B)(6) 2010 REPLACEMENT SURGERY.
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 | 44 YR | Other | IMPLANTABLE INFUSION PUMP: MODEL 8637-40,| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N227881008| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NGV442207H |