ASKU - BEUDAMED

Report

Report Number: 2182208-2010-00839
Event Type: Injury
Date Received: October 19, 2010
Date of Event: May 25, 2010
Manufacturer: MEDTRONIC, INC.
Product Code: DTB
PMA / PMN Number: ASKU
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

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. EVALUATION SUMMARY: (B)(4) DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. WITHOUT A LOT NUMBER OR LEAD SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED THE SYSTEM WAS REMOVED DUE TO INFECTION. SURGICAL NOTES RECEIVED REPORTED THAT PRIOR TO THE SYSTEM REMOVAL, THE PATIENT HAD COMPLAINED OF FLU-LIKE SYMPTOMS AND BLOOD DRAINAGE FROM THE IMPLANT SITE. PATIENT TREATED WITH INTRAVENOUS ANTIBIOTICS AND CULTURES CAME BACK POSITIVE FOR (B)(6). THE WOUND HEALED NICELY. ADDITIONAL INFORMATION WAS ALSO RECEIVED INDICATING THAT DURING THE INITIAL IMPLANT OF THIS SYSTEM BACK ON (B)(6) 2010, THE PATIENT HAD INCREASED CHEST TUBE DRAINAGE SECONDARY TO A LEFT PLEURAL EFFUSION THAT WAS DISCOVERED INTRAOPERATIVELY. A HEMATOMA OVER THE DEVICE POCKET AND A SMALL PNEUMOTHORAX WERE ALSO NOTED. THERE WAS ALSO REFERENCE TO A (B)(6) 2009 IMPLANT ATTEMPT WHERE A CS LEAD WAS UNABLE TO BE PLACED DUE TO INAPPROPRIATE PACING & THRESHOLDS SO A CS LEAD WAS NOT USED. FOLLOW-UP ATTEMPTS WERE UNABLE TO OBTAIN ADDITIONAL SPECIFIC INFORMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASKU	IMPLANTABLE PACING LEAD	DTB	MEDTRONIC, INC.	LEAD/UNK	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention