FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2070126
·
Received April 21, 2011
Report
- Report Number
- 3007566237-2011-02979
- Event Type
- Injury
- Date Received
- April 21, 2011
- Date of Event
- March 1, 2011
- Report Date
- April 6, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT HAD THEIR PUMP REPLACED. ON (B)(6) 2010, THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS ESTIMATED TO BE 26 MONTHS, HOWEVER, THE PT'S ERI OCCURRED EARLY ON (B)(6) 2011. A PHYSICIAN RECOMMENDED THAT THE PUMP BE REPLACED. THE PUMP WAS PLANNED TO BE SENT BACK TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT# N253758005| EXPLANTED:| CATHETER: MODEL 8703W, LOT# J0056588R |