MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-13 for LEAD ADAPTOR 501214 manufactured by Greatbatch Medical.
[136033676]
The returned device was not evaluated. The device went through at least one decontamination procedure using a high-level disinfectant (i. E. Cidex opa) in accordance with its manufacturer's recommendations and therefore, most if not all microorganisms were eliminated from the device. Since infection results from the presence of microorganisms, additional testing to attempt to identify the source of infection is not feasible.
Patient Sequence No: 1, Text Type: N, H10
[136033677]
It was reported that lead adapter was explanted due to infection/sepsis. Left surgical site infected from where ra and lv leads were tunneled to patient's abdomen. Leads and adapters were extracted and ports were plugged on the device. Pt does still have an rv lead that was tunneled from the right shoulder area. Pg and rv are not infected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183787-2019-00015 |
| MDR Report Key | 8335969 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-13 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2019-02-13 |
| 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 | RHONDA STAGER |
| Manufacturer Street | 2360 BERKSHIRE LANE |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7639518376 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD ADAPTOR |
| Generic Name | BIPOLAR LEAD ADAPTOR |
| Product Code | DTD |
| Date Received | 2019-02-13 |
| Returned To Mfg | 2019-01-28 |
| Model Number | 501214 |
| Lot Number | W3959484 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREATBATCH MEDICAL |
| Manufacturer Address | 2300 BERKSHIRE LANE PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-13 |