MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE ADAPTER

Model Number	6931
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report would be updated should information be provided at that time.(b)(4).
Event or Problem Description
It was reported that this adapter was abandoned, as lead where it was connected exhibited high pacing thresholds and noise, root cause was not determined.No additional adverse patient effects.
Additional Manufacturer Narrative
Product investigation did not confirm the reported observations.Adapter was found to be electrically continuous.Detailed analysis revealed surface abrasion but no through.Patient code 3191 captures the reportable event of surgery.
Event or Problem Description
It was reported that this adapter was abandoned, as lead where it was connected exhibited high pacing thresholds and noise, root cause was not determined.Later on the adapter was explanted an returned for analysis.No additional adverse patient effects.

• Brand Name: NA
• Common Device Name: IMPLANTABLE ADAPTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9653916
• Report Number: 2124215-2020-02247
• Device Sequence Number: 11487443
• Product Code: LWS
• UDI-Device Identifier: 00802526067884
• UDI-Public: 00802526067884
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P910073/S018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2009
• Device Model Number: 6931
• Device Catalogue Number: 6931
• Device Lot Number: 403747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 01/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR