FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1980364
·
Received February 3, 2011
Report
- Report Number
- 3004209178-2011-00842
- Event Type
- Injury
- Date Received
- February 3, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT DEVELOPED MENINGITIS AND EXPERIENCED COGNITIVE CHANGES. HE WAS HOSPITALIZED AND THE DEVICE SYSTEM WAS EXPLANTED. ORAL AND IV ANTIBIOTICS WERE ADMINISTERED. HE PARTIALLY IMPROVED WHEN LAST SEEN IN EARLY (B)(6) 2011. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. THE INFECTIOUS DISEASE SPECIALIST TOOK OVER, SO IT WAS UNK IF THE INFECTION RESOLVED.
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 | 61 YR | Hospitalization| R | EXTENSION: MODEL 7482A51, LOT# NHU218216V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V458448| EXPLANTED:| IMPLANTED: |