FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1885193
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08416
- Event Type
- Injury
- Date Received
- October 25, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 28, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SEE ALSO MANUFACTURER REPORT #3004209178-2010-08419. IT WAS REPORTED THAT THE PT EXPERIENCED A FALL. THE PT STATED THAT IT FELT "LIKE RUBBER" FROM BOTH KNEES, DOWN. THE FALL CAUSED THE PT TO INJURE BOTH KNEES AND THE HEAD. THE PT WAS HOSPITALIZED FOR THREE DAYS FOLLOWING THE FALL. THE PT WAS STILL "WOOZY." NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization | LEAD: MODEL 3389, LOT# J0337392V| LOT# NFW155454H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3389, LOT# J0337392V| EXTENSION: MODEL 7482, LOT# NGK017133N| IMPLANTED:| EXTENSION: MODEL 7482, LOT # NHU023366V| IMPLANTED: |