FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 2811630
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06528
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 11, 2012
- Report Date
- February 22, 2013
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- Z-2120-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY (B)(4) - THE DEVICE WAS RETURNED AND ANALYZED. THE PRIMARY ANALYSIS FINDING NOTED THE DEVICE INTEGRATED CIRCUIT INCLUSION ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. TWO PROGRAMMERS WERE USED WITHOUT SUCCESS. START SOFTWARE APPLICATION WAS TRIED INSTEAD OF AUTO IDENTIFICATION, BUT THE DEVICE WAS STILL UNABLE TO BE INTERROGATED. THE DEVICE WAS NOT 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 | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL, INC. | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |