FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1872227
·
Received October 14, 2010
Report
- Report Number
- 6000032-2010-07959
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- February 1, 2010
- Report Date
- September 17, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO. MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT REPORTED THAT THE TISSUE OVER HER IMPLANTABLE NEUROSTIMULATOR BECAME "BIGGER AND FLATTER" FOLLOWING A FULL-BODY CT SCAN. THE CT SCAN WAS APPROXIMATELY FIVE MINUTES LONG AND THE PT'S HEAD WAS NOT SCANNED. NO ADVERSE EVENT OCCURRED DURING THE CT SCAN. THE PT WAS STILL GETTING PAIN RELIEF AND HER PT PROGRAMMER WAS WORKING. THE PT'S HEALTH CARE PROFESSIONAL REPROGRAMMED HER DEVICE ON (B)(6) 2010. THE HCP REPORTED THAT THE PT HAD NO SIGNS OR SYMPTOMS AND NO INJURY OCCURRED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO. MED REL | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK003492V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# J0120595V| EXPLANTED:| UNKNOWN CONVERSION TYPE: MODEL 3550-09, LOT#L96558 |