FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1902215
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09562
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD THEIR SYSTEM REMOVED ON (B)(6) 2010. IT WAS STATED THE HEALTH CARE PROVIDER "REMOVED THE WHOLE SYSTEM ON THE LEFT SIDE; THE WIRES WERE CORRODED." THE DETAILS OF THE PROCEDURE AND PT OUTCOME WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO 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 | 65 YR | Required Intervention | IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V234237| EXTENSION: MODEL 7482A51, LOT# NHU193816V |