FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 1921770
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05830
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- July 7, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. ERI (ELECTIVE REPLACEMENT INDICATOR) RECORDED ON (B)(6) 2010.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS SHOWING ERI (ELECTIVE REPLACEMENT INDICATOR) PREMATURELY. IT WAS ALSO REPORTED THAT THE DEVICE WAS NOT DISPLAYING ANY BATTERY VALUES SUCH AS VOLTAGE AND IMPEDANCE. THE DEVICE REMAINS IN USE. 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. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Other | 4524 IMPLANTABLE PACING LEAD| 5034 IMPLANTABLE PACING LEAD |