FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 3071636
·
Received April 22, 2013
Report
- Report Number
- 3004209178-2013-06707
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- February 8, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT COMPLAINED THE DEVICE "KEEPS ME AWAKE ALL NIGHT". PATIENT REPORTED "BURNING INSIDE, ACHES, NO REDNESS OR SWELLING OUTSIDE". FOLLOW UP WITH THE PHYSICIAN'S OFFICE DISCLOSED PATIENT HAD BEEN SEEN COMPLAINING OF TENDERNESS AND SORENESS AT DEVICE SITE. REVISION PROCEDURE TO REPOSITION THE DEVICE WAS DISCUSSED. 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 |
|---|---|---|---|---|---|---|---|
| 173107 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDRL1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3830 X2 IMPLANTABLE PACING LEADS |