FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1844573
·
Received September 23, 2010
Report
- Report Number
- 3007566237-2010-07234
- Event Type
- Injury
- Date Received
- September 23, 2010
- Date of Event
- September 8, 2006
- Report Date
- June 11, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MANUFACTURER EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT EXPERIENCED INCREASED PAIN. THE PT'S PUMP WAS INVERTED, AND WAS SURGICALLY REPOSITIONED. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention | CATHETER: MODEL 8709, LOT# N005448228| IMPLANTED:| EXPLANTED: |