FDA Adverse Event
Malfunction
Summary report: N
INTREL 3
MDR report key: 1083381
·
Received July 28, 2008
Report
- Report Number
- 3004209178-2008-04463
- Event Type
- Malfunction
- Date Received
- July 28, 2008
- Date of Event
- May 1, 2008
- Report Date
- June 30, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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
IT WAS REPORTED THE PATIENT EXPERIENCED A LACK OF EFFECT ABOUT A MONTH AGO. IMPEDANCE READING WERE GREATER THAN 4000 OHMS ON ALL OR SOME BIPOLAR PAIRS. REPROGRAMMING WAS ATTEMPTED RESULTING IN STIMULATION IN THE TAILBONE, RIB AREA, OR NO STIMULATION SENSATION. THE PATIENT WAS TO UNDERGO X-RAYS TO CONFIRM A LEAD MIGRATION. NO OTHER SYMPTOMS OR OUTCOME WERE REPORTED. 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 | INTREL 3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED| EXTENSION MODEL 7489 LOT# NHU094317V| IMPLANTED| PROGRAMMER MODEL 7434A LOT# NGL026171P| EXPLANTED| IMPLANTED| LEAD MODEL 3487A-33 LOT# V003444| EXPLANTED| EXPLANTED |