FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1885265
·
Received October 25, 2010
Report
- Report Number
- 3004209178-2010-08386
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 30, 2010
- Manufacturer
- MDTPUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
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 IMPEDANCES WERE C/0-1446, C/1-1058, C/2-1803, C/4-1941 OHMS. ALL OTHER COMBINATIONS WERE >2000 OHMS. THE STIMULATOR APPEARED TO BE WORKING APPROPRIATELY. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE MFR. #3004209178-2010-08384 REGARDING THE SECOND DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDTPUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | LEAD: MODEL 3387, LOT#: V003110| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT#: V003110| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT#: NHU123237V| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT#: NHL017203P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT#: NHU123239V| EXPLANTED:| IMPLANTED:| MODEL 7426, LOT#: NFW134295H| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR| EXPLANTED: |