FDA Adverse Event
Injury
Summary report: N
SECURA DR
MDR report key: 3991718
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14241
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 6, 2014
- Report Date
- May 6, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
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. CONCOMITANT MEDICAL PRODUCTS: 6947-65, LEAD, IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CLINICIAN THOUGHT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR THE DEVICE NOT WITHHOLDING THERAPY. 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 |
|---|---|---|---|---|---|---|---|
| 466777 | SECURA DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D224DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Life Threatening | 5076-52 LEAD |