FDA Adverse Event
Malfunction
Summary report: N
SECURA DR
MDR report key: 1861808
·
Received October 8, 2010
Report
- Report Number
- 6000144-2010-04831
- Event Type
- Malfunction
- Date Received
- October 8, 2010
- Date of Event
- July 7, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STILL FEELS SORENESS IN THE DEVICE AREA 4 TO 5 MONTHS POST-IMPLANT. PATIENT DENIES THAT THERE IS ANY SWELLING OR REDNESS AND INDICATED THAT THE "MD HAS NO CONCERNS AND SAID TO TAKE TYLENOL". THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURA DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D224DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |