FDA Adverse Event
Injury
Summary report: N
TRIUMPH VR
MDR report key: 2448173
·
Received February 13, 2012
Report
- Report Number
- 2182208-2012-00037
- Event Type
- Injury
- Date Received
- February 13, 2012
- Date of Event
- October 13, 2011
- Report Date
- April 3, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- LWO
- PMA / PMN Number
- P850051/S34
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND NO ANALYSIS WAS COMPLETED AND THE DEVICE IS A COMPETITOR PRODUCT.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE EXPLANT PROCEDURE, DIFFICULTIES WERE ENCOUNTERED WITH REMOVING THE CHRONIC RIGHT VENTRICULAR LEAD FROM THE HEADER OF THE DEVICE. THE PHYSICIAN USED MINERAL OIL AND SALINE TO AID IN THE REMOVAL OF THE LEAD. ULTIMATELY, THE LEAD WAS ABLE TO BE REMOVED FROM THE HEADER AND THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIUMPH VR | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE | LWO | RICE CREEK MFG | 1124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |