FDA Adverse Event
Injury
Summary report: N
VERSA DR
MDR report key: 1921304
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05727
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 2, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. EVALUATION SUMMARY: (B)(4): BATTERY DEPLETION WAS NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE AND HIGH THRESHOLD ON BOTH RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS AND IT LED TO EARLY BATTERY DEPLETION. BOTH THE LEADS WERE CAPPED AND REPLACED AND THE DEVICE WAS 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 |
|---|---|---|---|---|---|---|---|
| 1 | VERSA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | VEDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization| R |