FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 4150869
·
Received October 8, 2014
Report
- Report Number
- 2124215-2014-16856
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- July 3, 2014
- Report Date
- September 1, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- PMA / PMN Number
- P970003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS AND OVERSENSED NOISE THAT RESULTED IN PACING INHIBITION. NO ASYSTOLE WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED AND INDICATED THAT LEAD FRACTURE WAS SUSPECTED. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 633217 | ALTRUA | IMPLANTABLE PULSE GENERATOR | LWP | GUIDANT CRM CLONMEL IRELAND | S602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Hospitalization| L| R | 4135| 4088| S602| 1298| 4087 |