FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1025566
·
Received April 4, 2008
Report
- Report Number
- 3004209178-2008-01806
- Event Type
- Injury
- Date Received
- April 4, 2008
- Date of Event
- February 1, 2008
- Report Date
- March 6, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Removal / Correction Number
- Z-0694-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SERIAL NUMBER IS INCLUDED IN THE RANGE FOR THE MEDTRONIC SOLETRA LIFTED BOND WIRE RECALL (DATED OCTOBER 2007).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A LACK OF THERAPEUTIC EFFECT. THE STATUS LIGHTS USING THE PT PROGRAMMER INDICATED A DEPLETED NEUROSTIMULATOR. ADDITIONAL INFO RECEIVED REPORTED THAT THE PT'S RIGHT SIDED SYSTEM WAS REMOVED DUE TO INFECTION. PT OUTCOME WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD MODEL 3389| EXTENSION MODEL 7482| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION MODEL 7482| EXPLANTED:| LEAD MODEL 3389 |