FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1885270
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08417
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- January 1, 2009
- Report Date
- November 24, 2009
- 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
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED BALANCE PROBLEMS SINCE THEIR DEVICE WAS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. REFERENCE MFR. REPORT # 3004209178200909501 FOR INFO ON LEFT SIDE DEVICE THAT WAS EXPLANTED (B)(6) 2010. REFERENCE MFR. REPORT # 3004209178201008421 FOR INFO ON LEFT SIDE DEVICE THAT WAS SUBSEQUENTLY IMPLANTED.
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 | 50 YR | IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V311858| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V311858| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU208167V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU204762V| EXPLANTED:| IMPLANTED:| LOT# NFW159056H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| LOT# NFW161261H| EXPLANTED: |