PROTECTA XT CRT-D
Report
- Report Number
- 9614453-2013-01091
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- March 4, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4076, IMPLANTABLE PACING LEAD, (B)(6) 2011; 4196, IMPLANTABLE PACING LEAD, (B)(6) 2011. (B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS, AND UPON INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EXCESSIVE NOISE OVERSENSING, INCLUDING T-WAVE OVERSENSING (TWOS). A FRACTURE WAS INITIALLY SUSPECTED, AS WELL AS A SETSCREW ISSUE. THE LEAD WAS REPROGRAMMED, AND A REVISION PROCEDURE WAS SCHEDULED. DURING THE REVISION PROCEDURE, THE DEVICE WAS DISCONNECTED FROM THE LEAD, AND A NEW DEVICE WAS CONNECTED TO THE EXISTING LEAD. NO NOISE WAS SEEN UPON CONNECTION TO THE NEW DEVICE, SO AS A RESULT, THE LEAD WAS CONSIDERED TO BE FUNCTIONING APPROPRIATELY, AND THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT THE PATIENT RECEIVED SEVERAL INAPPROPRIATE SHOCKS, AND UPON INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED EXCESSIVE NOISE OVERSENSING, INCLUDING T-WAVE OVERSENSING (TWOS). A FRACTURE WAS INITIALLY SUSPECTED, AS WELL AS A SETSCREW ISSUE. THE LEAD WAS REPROGRAMMED, AND A REVISION PROCEDURE WAS SCHEDULED. DURING THE REVISION PROCEDURE, THE DEVICE WAS DISCONNECTED FROM THE LEAD, AND A NEW DEVICE WAS CONNECTED TO THE EXISTING LEAD. NO NOISE WAS SEEN UPON CONNECTION TO THE NEW DEVICE, SO AS A RESULT, THE LEAD WAS CONSIDERED TO BE FUNCTIONING APPROPRIATELY, AND THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252138 | PROTECTA XT CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | IPG MFG SWITZERLAND | D314TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR | Hospitalization| L| R | 6947 IMPLANTABLE TACHY LEAD |