FDA Adverse Event
Injury
Summary report: N
KAPPA 900 DR
MDR report key: 3993656
·
Received August 8, 2014
Report
- Report Number
- 2647346-2014-00066
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 21, 2014
- Report Date
- June 21, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- Product Code
- DXY
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.
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: 459245 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), HOWEVER, A "BATTERY FAILURE" IS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468068 | KAPPA 900 DR | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MDT PUERTO RICO OPERATIONS CO, MED REL | KDR901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Hospitalization| R | 409252 LEAD |