FDA Adverse Event
Injury
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 3062182
·
Received April 16, 2013
Report
- Report Number
- 2649622-2013-05101
- Event Type
- Injury
- Date Received
- April 16, 2013
- Report Date
- February 25, 2013
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD INSULATION WAS DAMAGED. THE LEAD WAS REPAIRED USING TWO LAYERS OF SILICONE AND IT REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162970 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 419488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00087 YR | Hospitalization| R | D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |