FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2032499
·
Received March 24, 2011
Report
- Report Number
- 9614453-2011-02252
- Event Type
- Injury
- Date Received
- March 24, 2011
- Date of Event
- March 17, 2011
- Report Date
- January 19, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. TRAINING IS IN PLACE.
Description of Event or Problem · 1
RECEIVED INFO THE PT WAS EXPERIENCING INTERMITTENT STIMULATION. THE INS WAS INTERROGATED ON (B)(6) 2011 AND IMPEDANCE VALUES INDICATED A POSSIBLE FRACTURE. THE PT WAS REPROGRAMMED USING THE REMAINING ELECTRODES, BUT STIMULATION WAS NOT IN THE AREA OF PAIN. THE LEAD AND INS WERE EXPLANTED ON (B)(6) 2011 AND REPLACED. THERE WAS NO PT INJURY AND SHE RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC EUROPE SARL | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT # V013349 |