FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2023092
·
Received February 24, 2011
Report
- Report Number
- 3004209178-2011-01410
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 8, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT PROGRAMMER REPORTED AN ERROR CODE OF 514 (REJECT SPECIFIED PROGRAM SET INVALID) WHEN TRYING TO SYNCHING WITH THE INS. THE PATIENT ALSO EXPERIENCED A SHOCKING SENSATION WHILE THE SYNCHING WAS BEING ATTEMPTED. PATIENT WAS DIRECTED TO HER HCP AND THE HCP REPORTED THE INS WAS UNRESPONSIVE TO TELEMETRY ATTEMPTS BY THE PHYSICIAN PROGRAMMER, PATIENT PROGRAMMER AND RECHARGER. AN ATTEMPT WAS GOING TO BE MADE TO CLEAR THE ERROR CODE WITH THE PHYSICIAN PROGRAMMER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT. REFERENCE MFR REPORT # 3004209178201101411 FOR CONCOMITANT INS SYSTEM.
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 | 22 YR | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V591289013| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE149149N| EXPLANTED:| IMPLANTED:| LOT# NKF722990H| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,| ACCESSORY: MODEL 37752, LOT# NKA123645N| PROGRAMMER: MODEL 37743, LOT# NKE122319N| EXPLANTED:| LEAD: MODEL 3778, LOT# V591289012| LEAD: MODEL 39565-65, LOT# V473239004 |