FDA Adverse Event Other Summary report: N

DEXTRUS 4136

MDR report key: 2253172 · Received September 7, 2011

Report

Report Number: 1028232-2011-02014
Event Type: Other
Date Received: September 7, 2011
Date of Event: June 29, 2011
Report Date: August 23, 2011
Manufacturer: BIOTRONIK SE & CO. KG
Product Code: NVZ
PMA / PMN Number: P950037
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING THIS PARTICULAR DEVICE. THE MFG PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MFG PROCESS, WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MFG.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFO THAT THIS SYS EXHIBITED FLUCTUATIONS IN PACING IMPEDANCE. HOWEVER, MEASUREMENTS WERE NEVER NOTED AS BEING OUT OF RANGE. INAPPROPRIATE SHOCKS WERE ALSO OCCURRING AS A RESULT OF ATRIAL FIBRILLATION THAT WAS BEING PICKED UP ON THE VENTRICULAR CHANNEL. BASED ON THE LEAD POSITIONING VIEW FROM THE CHEST X-RAY, IT APPEARED THAT THE RV AND POSSIBLY ALSO THE RA LEAD WERE DISLODGED. IT DID NOT APPEAR THAT THERE WAS ANYTHING WRONG WITH THE ICD. THE PT INDICATED THAT THEY HAD RECENTLY RESUMED CARDIAC REHAB WHICH DID INVOLVE SOME ARM EXERCISES. TO DATE, INFO SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SVC. IT WAS RECOMMENDED BY THE TECHNICAL SVS CONSULTANT THAT THE DEVICE TACHY THERAPY BE TURNED OFF UNTIL A DECISION COULD BE MADE REGARDING THE LEADS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DEXTRUS 4136	PACER LEAD	NVZ	BIOTRONIK SE & CO. KG	358754

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other