FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1761194
·
Received July 15, 2010
Report
- Report Number
- 3004209178-2010-05507
- Event Type
- Malfunction
- Date Received
- July 15, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 17, 2010
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT WAS SEEN IN CLINIC TO REPROGRAM HIS IMPLANTABLE NEUROSTIMULATOR TO PROVIDE MORE STIMULATION COVERAGE TO HIS FEET. DEVICE INTERROGATION REVEALED OUT-OF-RANGE IMPEDANCES ON 5 OF THE 8 ELECTRODES. REPROGRAMMING WAS UNSUCCESSFUL IN IMPROVING COVERAGE WITHOUT ALSO PRODUCING INTOLERABLY HIGH STIMULATION IN HIS LEGS. THE HCP SUGGESTED INJECTIONS AND LEAD REPOSITIONING USING A RETROGRADE APPROACH TO CAPTURE MORE OF HIS FOOT PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | EXTENSION: MODEL 7489, LOT# NHU114893V| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT059191P| IMPLANTED:| LEAD: MODEL 3998, LOT# V005838| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU118252V| IMPLANTED: |