MAUDE Adverse Event Report: MEDTRONIC, INC.; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

Model Number	5832S
Medical Device Problem Codes	Device Sensing Problem (2917); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the claws of the surgical cables would tend to loosen easily after sterilization.It was indicated that this resulted in loss of capture while threshold testing, high impedances and variable sensing.The cables were returned for analysis.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: manufacturer's analysis confirmed the customer comment that the eight returned surgical cables were damaged.It was indicated that a connector on each cable had broken free from the cable.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• Common Device Name: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7683066
• Report Number: 2182208-2018-01284
• Device Sequence Number: 10975003
• Product Code: LWP
• UDI-Device Identifier: 00643169703346
• UDI-Public: 00643169703346
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P820003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: Health Professional
• Device Model Number: 5832S
• Device Catalogue Number: 5832S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 07/31/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/07/2018; 08/09/2018; 10/02/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention