FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1163607
·
Received September 17, 2008
Report
- Report Number
- 2182207-2008-05857
- Event Type
- Injury
- Date Received
- September 17, 2008
- Date of Event
- May 3, 2008
- Report Date
- August 19, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(URINARY INCONTINENCE), IT IS UNCLEAR WHEN THE DEVICES WERE IMPLANTED. TWO DIFFERENT DATES WERE PROVIDED (TWO DAY IN 2008) BUT WERE NOT LINKED TO A SPECIFIC PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THE PT DEVELOPED AN INFECTION. THE SYMPTOMS INCLUDED REDNESS, SWELLING AND URINARY INCONTINENCE. THE PRIMARY LOCATION OF THE INFECTION WAS THE NEUROSTIMULATOR POCKET AND LEAD TRACK. CULTURES WERE OBTAINED; THE TYPE OF ORGANISM CULTURED WAS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). THE PT WAS TREATED WITH IV ANTIBIOTICS AND BILATERAL TOTAL DEVICE SYSTEM EXPLANT. THE INFECTION RESOLVED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT #2182207200805856.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | MHY | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED| IMPLANTABLE PULSE GENERATOR MODEL UNK LOT# UNK| EXTENSION (X2) MODEL UNK LOT# UNK| EXPLANTED| LEADS (X2) MODEL UNKL LOT# UNK| IMPLANTED |