FDA Adverse Event
Injury
Summary report: N
PROTECTA XT DR
MDR report key: 3992335
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14846
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- December 1, 2013
- Report Date
- June 10, 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
- NC, US
- Reporter Occupation
- PHYSICIAN
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 PRODUCT: 5076-45, LEAD, IMPLANTED: (B)(6) 2011. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK THAT THE ELECTROPHYSIOLOGIST BELIEVES TO BE INAPPROPRIATE. 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 |
|---|---|---|---|---|---|---|---|
| 468384 | PROTECTA XT DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D314DRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Life Threatening | 694765 LEAD |