FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1951961
·
Received January 4, 2011
Report
- Report Number
- 3004209178-2011-00056
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 23, 2010
- 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
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED NO STIMULATION SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. INTERROGATION NOTED GETTING QUESTION MARKS (???) IN THE RESULTS. AFTER RE-RUNNING TEST IMPEDANCES READ >4000 OHMS ON SOME OF THE BIPOLAR PAIRS. NO INTERVENTION OR OUTCOME WAS REPORTED. FURTHER TROUBLESHOOTING WAS BEING CONSIDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7427V | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT053903P| LEAD: MODEL 3487A, LOT# J0537698V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU100213V| EXTENSION: MODEL 7489, LOT# NHU100214V| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0537697V |