MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-06-10 for 13005-55T10 manufactured by Medtronic, Inc..
[4565255]
It was reported that the tunneling tool broke during the process of tunneling the lead into the pocket. Another tool was used. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12116835]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15765988]
Product event summary: the lead accessories were analyzed; visual summary analysis of the lead indicated damage at implant. The analyst noted: the proximal end of the tunneling rod is broken off.
Patient Sequence No: 1, Text Type: N, H10
[99374978]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2014-01767 |
| MDR Report Key | 3861287 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-06-10 |
| Date of Report | 2014-03-28 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2014-07-07 |
| Date Added to Maude | 2014-06-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | TOOLS, PACEMAKER SERVICE |
| Product Code | DTF |
| Date Received | 2014-06-10 |
| Returned To Mfg | 2014-04-02 |
| Model Number | 13005-55T10 |
| Catalog Number | 13005-55T10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5071 | 2014-06-10 |