FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2900245
·
Received January 7, 2013
Report
- Report Number
- 3004209178-2013-00258
- Event Type
- Injury
- Date Received
- January 7, 2013
- Report Date
- December 11, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A WOUND DEHISCENCE AT THE PUMP POCKET AND A SURGICAL EXPLANT OF HIS SYSTEM. THE SYMPTOMS PRESENT WERE "DRAINAGE AND THE INCISIONAL WOUND OPENING". IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED, BUT THE PATIENT'S STATUS WAS NOTATED AS "NO INJURY AND NO ADVERSE EVENT". THE DRUG USED IN THIS SYSTEM WAS LIORESAL. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6550 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR | Hospitalization| R |