RESTORE PRIME ADVANCED
Report
- Report Number
- 3004209178-2010-08816
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Date of Event
- October 2, 2009
- Report Date
- October 12, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). FINAL DEVICE ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: INS CONNECTOR PORT HAS A LEAD INSERTION ANOMALY: A LEAD WILL NOT FULLY INSERT INTO THE 8-15 PORT. LEAD COMES TO A HARD STOP AT THE #14 BALSEAL CONNECTOR COIL. AT FIRST, A LEAD WOULD NOT PASS THROUGH THE #6 BALSEAL EITHER. DURING ANALYSIS THE LEAD FULLY SEATED IN THE 0-7 PORT. X-RAYS REVEAL NO VISIBLE ANOMALIES OF BALSEAL CONNECTOR COILS. THE #14 BALSEAL ASSEMBLY IS OUT OF ALIGNMENT WITH THE OTHER BALSEALS. THE PROXIMAL END OF THE LEAD USED FOR TESTING MEASURED .050 IN DIAMETER. THE LARGEST GAGE PIN THAT WILL PASS THROUGH THE #14 BALSEAL IS .042 AND CAN BE FELT DRAGGING ON THE CONNECTOR COIL.
IT WAS REPORTED THE PT'S DEVICE WAS SHOWING HIGH IMPEDANCE READINGS OF >40,000 OHMS AT IMPLANT. THE PT'S HEALTH CARE PROVIDER "SWAPPED LEAD ENDS" AND RETESTED, WITH SIMILAR IMPEDANCE READINGS OF >40,000 OHMS. THE LEAD WAS TESTED IN A SNAP-LID, AND ALL MEASUREMENTS WERE NORMAL. WHEN THE HCP ATTEMPTED TO REINSERT THE LEAD INTO THE DEVICE, THE HCP REPORTED "THE LEAD WILL NOT INSERT ALL THE WAY." IT WAS DECIDED TO REPLACE THE DEVICE. THE DEVICE WAS REPLACED AND THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LEAD: MODEL 39565, LOT #UNK| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #UNK| EXPLANTED:| IMPLANTED:| IMPLANTED: |