FDA Adverse Event
Malfunction
Summary report: N
SECURA DR
MDR report key: 1862936
·
Received October 9, 2010
Report
- Report Number
- 6000144-2010-05023
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT COMPLAINS OF "FEELING TERRIBLE" DURING THE DAY. THE FEELING IN HER CHEST AND DEVICE POCKET IS DESCRIBED AS "PUTTING A BATTERY ON THE TONGUE". THE FEELING OCCURS MORE AT HIGHER OUTPUTS, PATIENT STATES. NO DIAPHRAGMATIC STIMULATION WAS NOTED AT HIGHER OUTPUTS. SYSTEM REMAINS IMPLANTED. NO PATIENT COMPLICATIONS WERE 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 | 46 YR | Other | 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |