FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2061915
·
Received April 5, 2011
Report
- Report Number
- 3004209178-2011-02602
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 18, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECTIVE AND INTERMITTENT STIMULATION AFTER SIX ULTRASOUND TREATMENTS. SHE ALSO REPORTED A BURNING SENSATION IN THE POCKET AREA. FEELS LIKE THE STIMULATION IS TURNING ON/OFF. THE PATIENT HAD THE STIMULATOR TURNED OFF DURING THE ULTRASOUND TREATMENTS. IT IS UNKNOWN IF SYMPTOMS OCCUR WITH THE STIMULATION ON OR OFF. AN X-RAY OF THE LEAD AND EXTENSION AREA WAS RECOMMENDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
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 | 54 YR | EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE128780N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB041358V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V313951005| LEAD: MODEL 3778, LOT# V247482017 |