FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2093972
·
Received May 16, 2011
Report
- Report Number
- 3007566237-2011-03538
- Event Type
- Injury
- Date Received
- May 16, 2011
- Date of Event
- March 3, 2011
- Report Date
- August 23, 2016
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CORRECTED INFORMATION: ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WERE REPLACED. CONCLUSION CODE NO LONGER APPLICABLE.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE (B)(6) 2011.
Description of Event or Problem · 1
A PATIENT'S PUMP POCKET INFECTION RESULTED IN PROLONGED HOSPITALIZATION. UPON EXAMINATION/PALPATION ON (B)(6) 2011, THE POCKET INFECTION WAS DETERMINED. THE PATIENT HAD THE FOLLOWING SYMPTOMS: HEADACHE, NECK PAIN, AND FEVER. THE PUMP ADMINISTERED LIORESAL (500.0 MCG/ML AT 50.04 MCG/DAY). THE PUMP WAS EXPLANTED, AND CATHETER INTERVENTION WAS INDICATED AS OCCURRING ON THE SAME DAY. THE PATIENT'S OUTCOME WAS NOTED AS ON-GOING. ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP REPORT, AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R | IMPLANTED:| EXPLANTED: |