FDA Adverse Event
Injury
Summary report: N
ELECTRODE, PACEMAKER, PERMANENT
MDR report key: 2953673
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01288
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- December 27, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P930039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 4470, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2009; 0185, COMPETITOR IMPLANTABLE TACHY LEAD, (B)(4) 2009; 4543, COMPETITOR IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK ATTRIBUTED TO NOISE OBSERVED ON THE LEAD. A LEAD FRACTURE WAS SUSPECTED. IT WAS ALSO REPORTED THAT THE PATIENT FELL FROM A LADDER AND LANDED ON THE SHOULDER WITH THE DEVICE IMPLANT PRIOR TO THIS EVENT. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55616 | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 5076-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00046 YR | Hospitalization| L| R | (B)(4) COMPETITOR IMPLANTABLE PULSE GENERATOR |