FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2251140
·
Received September 8, 2011
Report
- Report Number
- 3004209178-2011-07535
- Event Type
- Malfunction
- Date Received
- September 8, 2011
- Date of Event
- August 18, 2011
- Report Date
- August 19, 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING TWO FALLS. THE PT WAS WALKING AND FELL OVER A CEMENT DIVIDER ON THE ROAD FOR DRAINAGE. THE PT HIT THE GROUND HARD. THE PT THEN FELL AGAIN RIGHT AFTER THE INITIAL FALL. BOTH FALLS WERE ON (B)(6) 2011. SINCE THE FALLS, THE PT HAD A RETURN OF SYMPTOMS AND WAS NOT FEELING STIMULATION. ADDITIONALLY, THE PT EXPERIENCED ADDED PAIN FROM THE FALL. AN X-RAY OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND EXTENSION AREA WAS RECOMMENDED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | EXPLANTED:| LEAD: MODEL 39565-65, LOT# V592238047| PROGRAMMER: MODEL 37743, LOT# NKE162265N| IMPLANTED: |