FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 1923072
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-06039
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- October 1, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT, AFTER SEWING THE PATIENT, IT WAS NOTICED THAT THE ATRIAL AND VENTRICULAR LEADS CONNECTIONS IN THE DEVICE PORTS WERE REVERSED. THE PATIENT POCKET WAS REOPENED, AND THE LEADS CONNECTIONS WERE CORRECTED. THE DEVICE REMAINS IN USE. 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 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R | 4076X2 IMPLANTABLE PACING LEAD |