FDA Adverse Event
Malfunction
Summary report: N
PROTECTA XT CRT-D
MDR report key: 2811528
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-06321
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- September 28, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S178
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. EVALUATION SUMMARY: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE LEAD IMPEDANCES THROUGH THE ANALYZER WERE WITHIN NORMAL RANGE. ONCE ATTACHED TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALL IMPEDANCES WERE OUT OF RANGE. THE ICD WAS REMOVED AND ANOTHER ONE ATTACHED TO THE LEADS WITH ACCEPTABLE IMPEDANCES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTECTA XT CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D314TRM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |