FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1822601
·
Received August 27, 2010
Report
- Report Number
- 3004209178-2010-06542
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- July 26, 2010
- Report Date
- July 30, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO. JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE IMPLANTABLE NEUROSTIMULATOR AND EXTENSION HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IMPLANTABLE NEUROSTIMULATOR AND EXTENSION REMOVED DUE TO INFECTION IN RIGHT CHEST. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 53 YR | Required Intervention | EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU212382V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V280394| IMPLANTED: |