FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 2810720
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06271
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- June 13, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- Z-2120-2011
- 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. EVALUATION SUMMARY: (B)(4). THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A MEDICAL COMPLICATION/INJURY; HOWEVER, THE REPORT ALSO INDICATED THAT THERE WAS NO DEVICE PERFORMANCE ISSUE. THE DEVICE WAS EXPLANTED AND REPLACED. THREE ATTEMPTS WERE MADE TO COLLECT MORE INFORMATION REGARDING THE EVENT BUT NO INFORMATION WAS OBTAINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization| R | 4524 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD |