FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1930313
·
Received November 24, 2010
Report
- Report Number
- 3004209178-2010-09955
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- September 29, 2010
- Report Date
- November 16, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AS WELL AS A SHOCKING OR JOLTING SENSATION. THE EVENT STARTED AT IMPLANT ON (B)(6) 2010. THE PATIENT HAD AN APPOINTMENT WITH THE HEALTHCARE PROVIDER ON (B)(6) 2010. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | LEAD: MODEL 3778, LOT# V545114013| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V545114012| PROGRAMMER: MODEL 37743, LOT# NKE154973N| EXPLANTED: |