MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION STREAMLINE TEMPORARY PACING LEADS; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6500P

Device Problems Pacing Problem (1439); Failure to Sense (1559); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

End date of survey results used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information through a post market clinical follow-up survey on the medtronic streamline unipolar temporary myocardial pacing wire (model 6500).The healthcare professional reported two instances of lead dislodgment due to suturing technique.These instances were reported as related to the device.Three instances of "high threshold" due to "poor choice of pacing site placement" were reported and were related to the device.One instance of "lead retention" that was related to the procedure but not directly to the device itself was reported.One instance was "phrenic nerve stimulation" due to "site placement" was reported and related to the device.The healthcare professional reported two instances of "loss of pacing" due to "improper suturing".One instance was related to the procedure but not directly to the device, the other instance was related to the device.No unique device identifier numbers were provided.No additional adverse patient effects or product performance issues were reported.

• Brand Name: STREAMLINE TEMPORARY PACING LEADS
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13114924
• MDR Text Key: 286244778
• Report Number: 3008592544-2021-00049
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6500P
• Device Catalogue Number: 6500P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1