FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1993785
·
Received January 13, 2011
Report
- Report Number
- 3004209178-2011-00344
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Report Date
- January 4, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A SHOCKING/JOLTING SENSATION. DETAILS WERE UNK. THE PT HAD RELOCATED AND WAS SEEKING A NEW PHYSICIAN. FURTHER INFO IS BEING REQUESTED AT THIS TIME.
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 | EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB052909V| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N191911001| ACCESSORY: MODEL 37752, LOT# NKA127799N| PROGRAMMER: MODEL 37743, LOT# NKE130548N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB053553V| EXPLANTED:| EXPLANTED:| IMPLANTED: |