FDA Adverse Event
Injury
Summary report: N
N/A
MDR report key: 2953246
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01914
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- November 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. A HIGH CURRENT DRAIN CONDITION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED THE HYBRID WAS DAMAGED DURING ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4).
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 DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR FOUR YEARS AFTER IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57043 | N/A | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | VEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00083 YR | Hospitalization| R | 4076 X2 IMPLANTABLE PACING LEADS |