FDA Adverse Event
Malfunction
Summary report: N
ITREL II
MDR report key: 1812280
·
Received August 16, 2010
Report
- Report Number
- 6000032-2010-06164
- Event Type
- Malfunction
- Date Received
- August 16, 2010
- Date of Event
- January 1, 2000
- Report Date
- July 15, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED, 8 TO 10 YEARS AGO, THE HCP DISCOVERED THE LEAD HAD FRACTURED AND WAS CAUSING SHOCKING SENSATIONS. THE PT HAD NOT EXPERIENCED ANY FALLS OR TRAUMA THAT MAY HAVE CAUSED THE FRACTURE. THE BATTERY FOR THE DEVICE SYSTEM HAD DIED SO, THE SHOCKING HAD CEASED BUT THE IMPLANT REMAINED IN THE PT'S BODY. THE PT WAS REQUESTING REMOVAL OF THE DEVICE FOR PURPOSES SUCH AS AN MRI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL II | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7424 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | EXPLANTED:| PROGRAMMER: MODEL 7433, LOT# QV1009345P| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXTENSION: MODEL 7495-51, LOT# XR0018824N| IMPLANTED:| EXPLANTED:| IMPLANTED: |