FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 1071624
·
Received July 9, 2008
Report
- Report Number
- 6000032-2008-03882
- Event Type
- Injury
- Date Received
- July 9, 2008
- Date of Event
- May 1, 2008
- Report Date
- June 10, 2008
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE PT EXPERIENCED IN INTERMITTENT LOSS OF THERAPY. THERE WAS A LOOSE CONNECTION BETWEEN THE IMPLANTABLE PULSE GENERATOR AND THE EXTENSION. THE IMPLANTABLE PULSE GENERATOR WAS REPLACED AND THERAPY CONTINUED WITH NO KNOWN PROBLEMS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L 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 | Required Intervention | IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL 7489 LOT# NHU035502V| LEAD MODEL 3998 LOT# J0357387V| EXPLANTED |