FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 2063772
·
Received April 15, 2011
Report
- Report Number
- 3004209178-2011-02867
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- January 1, 2010
- Report Date
- March 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD A REVISION BECAUSE THEIR LEADS WERE "MISPLACED." THE DETAILS OF THE REVISION WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. REFERENCE MFR REPORT # 3004209178-2011-02866.
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 | 76 YR | Required Intervention | EXPLANTED:| LEAD MODEL: LEADMVD, LOT# UK6117233| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU022181V| IMPLANTED:| EXPLANTED:| LOT# NFW165425H| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V526050| EXTENSION: MODEL 7482, LOT# NHU022182V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED: |