FDA Adverse Event
Malfunction
Summary report: N
SECURA DR
MDR report key: 1991807
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00941
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- December 18, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, 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
THE PATIENT REPORTED HEARING A 3-4 SECOND BEEP COMING FROM THE DEVICE, AND RECEIVING A SHOCK, THE DAY AFTER, WHILE STRETCHING THEIR ARMS BEHIND THE BACK. THE PATIENT ALSO REPORTED FEELING DIZZY AND LIGHTHEADED SINCE RECEIVING THE SHOCK. IT WAS NOTED THAT THE PATIENT HAD ARM LIFTING AND MOVING RESTRICTIONS FOR A PERIOD THAT EXTENDED FOR ANOTHER 2 WEEKS. THE DEVICE REMAINS 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 | 47 YR | Other | (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD |