FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1890213
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08281
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- January 1, 2010
- Report Date
- June 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
THE PT HAD GASTRIC BYPASS SURGERY IN 2003 AND "LOST A LOT OF WEIGHT WHICH LEFT A LOT OF FLAB." AS A RESULT, THE IMPLANTABLE NEUROSTIMULATOR WAS "FLIPPING AND FLOPPING IN STOMACH" AND "FLIPS OUT" WHEN THE PT SITS DOWN. THE PT FELT LIKE THE INS WAS "TURNING." THE PT WAS ABLE TO COMMUNICATE WITH THE INS AND RECHARGE THE SYSTEM. THE PT STATED THE THERAPY WAS "HELPING WITH MEDICATION." ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | ACCESSORY: MODEL 37752, LOT # NKA135882N| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT # V418071001| EXPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE141438N| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB073346V| IMPLANTED: |