FDA Adverse Event
Injury
Summary report: N
TENAX
MDR report key: 9216433
·
Received October 21, 2019
Report
- Report Number
- 2182208-2019-01883
- Event Type
- Injury
- Date Received
- October 21, 2019
- Date of Event
- October 3, 2019
- Report Date
- October 21, 2019
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- K772203
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: 5866-37M X2 ADAPTOR, IMPLANTED (B)(6) 1982; 328-352 TELE/CORDIS LEAD, IMPLANTED (B)(6) 1982; 419488 LEAD, IMPLANTED (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED LOW IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1010504 | TENAX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MEDTRONIC, INC. | 6961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |