FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1052624
·
Received May 27, 2008
Report
- Report Number
- 3004209178-2008-02804
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- August 1, 2006
- Report Date
- November 13, 2006
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS A RESULT OF AN INTERNAL AUDIT, THIS REPORT IS BEING SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT SUBSEQUENT TO BATTERY REPLACEMENT, THE PT DEVELOPED A STAPH INFECTION AND THE RIGHT-SIDED BATTERY AND 'SYSTEM' WAS REMOVED. REVIEW OF THE DEVICE TRACKING SYSTEM INDICATES THE BILATERAL LEADS HAD REMAINED IMPLANTED; BOTH EXTENSION PRODUCTS WERE REPLACED. NO OTHER SYMPTOMS WERE REPORTED. THE CURRENT PT STATUS SHOWED NO TREMOR SYMPTOMS HAD BEEN DETECTED AFTER THE SURGICAL PROCEDURE. ATTEMPTS TO FOLLOW-UP WITH THE HCP FOR ADDITIONAL INFO WERE MADE AT THE TIME OF THE REPORTED EVENT WITHOUT SUCCESS.
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 | EXPLANTED:| EXPLANTED| DBS LEAD MODEL UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| DBS LEAD MODEL UNK| IMPLANTED:| DBS EXTENSION MODEL UNK| DBS EXTENSION MODEL UNK| LOT # NFW136026H| LEFT-SIDED IMPLANTABLE NEURO STIMULATOR MODEL 7426| IMPLANTED:| EXPLANTED:| IMPLANTED |