FDA Adverse Event
Injury
Summary report: N
PROTECTA CRT-D
MDR report key: 4834352
·
Received June 10, 2015
Report
- Report Number
- 3004209178-2015-11090
- Event Type
- Injury
- Date Received
- June 10, 2015
- Date of Event
- April 13, 2015
- Report Date
- April 13, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, 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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. CONCOMITANT PRODUCT/(S): 4194-78 LEAD, IMPLANTED: (B)(6) 2013. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD UNEXPECTED LONGEVITY ALTHOUGH ELECTIVE REPLACEMENT INDICATOR HAD NOT BEEN REACHED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378159 | PROTECTA CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | D334TRG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00075 YR | Hospitalization| R | 5076-52 LEAD, 6947-65 LEAD |