PROGRAMMING HEAD Adverse Event — Malfunction (MDR 2182208-2020-00821)
PROGRAMMING HEAD Adverse Event — Malfunction (MDR 2182208-2020-00821) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROGRAMMING HEAD; Generic name: PROGRAMMER, PACEMAKER; Manufacturer: MEDTRONIC, INC..
| Device | PROGRAMMING HEAD |
|---|---|
| Generic name | PROGRAMMER, PACEMAKER |
| Manufacturer | MEDTRONIC, INC. |
| Report number | 2182208-2020-00821 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | PRODUCT ANALYSIS: THE ANALYSIS FOUND THAT THE RADIO FREQUENCY (RF) HEAD CABLE TESTED OUT OF SPECIFICATION AND IT WAS NOTED TO SHUT DOWN THE PROGRAMMER. THE RADIO FREQUENCY (RF) HEAD NEEDS A NEW CABLE. THE RADIO FREQUENCY (RF) HEAD WILL BE REPAIRED AT A LATER DATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. |
| Source | openFDA MAUDE (device adverse events) |
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