FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2852956
·
Received November 30, 2012
Report
- Report Number
- 3004209178-2012-10984
- Event Type
- Injury
- Date Received
- November 30, 2012
- Report Date
- November 1, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID LEAK.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A POST-DURAL PUNCTURE HEADACHE. THE SIGNS AND SYMPTOMS WERE HEADACHE AND NAUSEA. THE SEVERITY WAS MILD. IT WAS RELATED TO THE IMPLANT PROCEDURE. INTERVENTION WAS EPIDURAL BLOOD PATCH ON (B)(6) 2012 AND MEDICATION: NO-DOZ (CAFFEINE) 200MG BY MOUTH Q4H PRN AND ZOFRAN 4MG IV Q8H PRN. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. THE PUMP WAS DELIVERING DILAUDID, DROPERIDOL AND BUPIVACAINE .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR | Required Intervention |