FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME
MDR report key: 2000266
·
Received February 17, 2011
Report
- Report Number
- 3004209178-2011-01195
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- January 1, 2010
- Report Date
- January 31, 2011
- 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
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PT'S HEALTH CARE PROVIDER THAT THE PT UNDERWENT A LEAD REVISION DUE TO A FALL. THE DATE AND DETAILS OF THE FALL AND REVISION AND PT OUTCOME WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. REFERENCE MFR. REPORT # 3004209178201101196.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427V,| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB003171V| PROGRAMMER: MODEL 37742, LOT # NJD022519N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT # V004859| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT # NFT041594P| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT # NHU049465V| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3987A, LOT # LC0784| EXTENSION: MODEL 7489, LOT # NHU053433V| LOT # NFE405156H| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3987A, LOT # LC2024| EXPLANTED: |