FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 2100639
·
Received May 12, 2011
Report
- Report Number
- 3004209178-2011-03452
- Event Type
- Injury
- Date Received
- May 12, 2011
- Date of Event
- April 18, 2011
- Report Date
- June 18, 2012
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND SIDE AFFECTS IN FACE WHICH FELT LIKE SHOCKING. C/0 1672 AND 12, C/1 445 AND 26, C/2 445 AND 26, C/3 >2000 AND 11UA PROGRAMMED AT 0-2+,120/185 AND 2V. ONE THOUSAND THREE HUNDRED AND FORTY 0/2 1347 AND 13UA, 0/3 >2000 AND 9UA, 1/3 1467 AND 12UA, 1/2 100 AND 76UA SHORT CIRCUIT WITH 1/2 NEED TO ESTABLISH INTEGRITY WITH 3 REVIEWED PROGRAMMING OPTIONS. BATTERY AT 3.72V. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7726 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention | EXTENSION: MODEL 7482, LOT# NGK018646N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT#N22928| LEAD: MODEL 3387, LOT#N22928| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NGK018646N |