FDA Adverse Event
Injury
Summary report: N
VIVA XT
MDR report key: 6160650
·
Received December 9, 2016
Report
- Report Number
- 3004209178-2016-25639
- Event Type
- Injury
- Date Received
- December 9, 2016
- Date of Event
- October 6, 2016
- Report Date
- October 6, 2016
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS : 6947-65 LEAD, IMPLANTED: (B)(6) 2009, 4196-88 LEAD , IMPLANTED: (B)(6) 2009. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
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 PATIENT EXPERIENCED PHRENIC NERVE AND DIAPHRAGMATIC STIMULATION DUE TO THE LEFT VENTRICULAR LEAD. THE LEAD ALSO HAD HIGH THRESHOLD. IT WAS ALSO REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION. THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808069 | VIVA XT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | DTBA1D1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R | 3830-69 LEAD |