FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1902195
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09550
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- October 1, 2010
- Report Date
- November 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S IMPLANTED DEVICE SYSTEM WAS REMOVED DUE TO A POCKET INFECTION (NO FURTHER DESCRIPTION OR CAUSATIVE ORGANISM WAS PROVIDED). NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention | EXPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 200820001| LEAD: MODEL 3777, LOT# V557941002| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA143548N| STIM ACCESSORY: MODEL 3555, LOT# N256608| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V557941002| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE155746N| IMPLANTED:| IMPLANTED: |