FDA Adverse Event
Malfunction
Summary report: N
PROTECTA DR
MDR report key: 2203845
·
Received August 11, 2011
Report
- Report Number
- 6000094-2011-01676
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- June 23, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S211
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 IMPLANT, THE DEVICE FAILED TO DETECT VENTRICULAR FIBRILLATION (VF) AND INITIATE THERAPY DURING VF INDUCTION. A MANUAL SHOCK OF 25J WAS DELIVERED THROUGH THE DEVICE. THE DEVICE WAS NOT IMPLANTED AND IT WAS REPLACED WITH A NEW ONE. 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 DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC S.A. | D334DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |