FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 1870727
·
Received October 12, 2010
Report
- Report Number
- 3004209178-2010-07879
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- December 1, 2005
- Report Date
- February 13, 2009
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED SHORTLY AFTER THE SPINAL CORD STIMULATOR WAS REPLACED (SEE MFR REPORT # 3004209178-2010-07880) THE PT HAD CONTINUED PAIN AND SWELLING OF THE DORSAL THORACIC WOUND AND A FEVER OF 103 FAHRENHEIT. NEEDLE ASPIRATION OF THE DORSAL THORACIC SITE OBTAINED A SMALL AMOUNT OF (B)(6). THE PT WAS ADMITTED TO THE HOSPITAL, IV ANTIBIOTICS WERE STARTED, AND A CT SCAN WAS PERFORMED SHOWING A SMALL "POCKET" AROUND THE ELECTRODE LEAD. THE ABDOMINAL POCKET ALSO BECAME SWOLLEN. THE DEVICE WAS EXPLANTED AND THERE WAS A COMPLETE RESOLUTION OF THE INFECTION. FOR INFO ABOUT EVENTS FOLLOWING THE EXPLANT, SEE MFR REPORT # 3004209178-2010-07881.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization| O| R | IMPLANTED:| LEAD: MODEL 3587A, LOT# L32195| EXPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0002309N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU077694V| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3587A, LOT# LA7357| IMPLANTED:| PROGRMMMER: MODEL 7434, LOT# YN0008036P| LOT # NAT150407H| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| EXPLANTED: |