FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1983070
·
Received February 4, 2011
Report
- Report Number
- 3004209178-2011-00881
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- December 31, 2010
- 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 PATIENT DEVELOPED MENINGITIS, CEREBRAL ABSCESS, PULMONARY EMBOLISM AND COGNITIVE CHANGES. FOLLOWING TOTAL DEVICE SYSTEM EXPLANT THE PATIENT EXPERIENCED RECURRENT TREMORS, PULMONARY EMBOLISM AND WORSENING CEREBRAL ABSCESS. IV ANTIBIOTICS AND ANTICOAGULANT WERE ADMINISTERED. A PICC LINE WAS PLACED FOR LONG TERM ANTIBIOTICS. THE INFECTION HAD NOT BEEN RESOLVED AND IV ANTIBIOTICS WERE STILL BEING ADMINISTERED. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. IT WAS SENT TO THE MICROBIOLOGY LAB AND THEN DISCARDED.
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 | 75 YR | Required Intervention | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU228259V| LEAD: MODEL 3387S, LOT# V515921| IMPLANTED:| IMPLANTED: |