FDA Adverse Event
Malfunction
Summary report: N
INTREL 3
MDR report key: 2209800
·
Received August 2, 2011
Report
- Report Number
- 6000032-2011-05979
- Event Type
- Malfunction
- Date Received
- August 2, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 7, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., MED REL
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
AN END-OF-SERVICE/END-OF-LIFE MESSAGE WAS REPORTED. IT WAS REPORTED THAT IMPEDANCE MEASUREMENTS ON SOME BIPOLAR PAIRS AND SOME OR ALL UNIPOLAR PAIRS WERE >4,000 OHMS. IMPEDANCES <250 OHMS WERE ALSO REPORTED. SPECIFIC IMPEDANCE MEASUREMENTS WERE AS FOLLOWS: C0: ???, C1: >4,000K, C2: >4,000K, C3: >4,000K, 01: <50 OHMS, 02: >4,000K, 03: >4,000K, 12: <50 OHMS, 13: 2135 OHMS, 23: 2047 OHMS. NO FURTHER DIAGNOSTICS OR INTERVENTIONS HAD TAKEN PLACE. THE NEUROSTIMULATOR WAS AT END-OF-LIFE AND WAS GOING TO BE REPLACED WHEN AUTHORIZED BY THE PT'S INSURANCE COMPANY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTREL 3 | LGW | MDT PUERTO RICO OPERATIONS CO., MED REL | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | PROGRAMMER: MODEL 7434, LOT #YN0024963P| EXPLANTED:| LEAD: MODEL 3887, LOT #L58534| IMPLANTED:| EXTENSION: MODEL 7495-25, LOT #NAF007333N| EXPLANTED:| IMPLANTED: |