FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2061922
·
Received April 5, 2011
Report
- Report Number
- 3004209178-2011-02625
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 18, 2011
- Report Date
- March 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. SENSATION WAS LOCATED AT THE INS SITE FOLLOWING AN IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE153382N| ACCESSORY: MODEL 37752, LOT# NKA144444N| LEAD: MODEL 39286-65, LOT# V398452007| IMPLANTED: |