FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 2201446
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-03767
- Event Type
- Injury
- Date Received
- August 11, 2011
- 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
- MO, 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 FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND THAT IT ONLY LASTED FOR TWO YEARS. THE DEVICE WAS REMOVED AND ANOTHER WAS IMPLANTED. NO 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. | ADDR06 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Hospitalization| R | 1013M COMPETITOR IMPLANTABLE PACING LEAD| 859F COMPETITOR IMPLANTABLE PACING LEAD |