MAUDE Adverse Event Report: HEART VALVES SANTA ANA MEDTRONIC TEMPORARY PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number MDT-TEMP LEAD

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 12/01/1995

Event Type  Injury  

Event Description

Medtronic received information via literature regarding an assessment of medtronic temporary pacing leads used with patients after cardiac surgery.All data were collected from a single center.The study population included 15 children (age range 3 months to 7 years, body weight range 4.4 to 20 kg) and 15 adults (age range 45 to 78 years).All patients were implanted with a medtronic 6491 or 6492 temporary pacing lead (unique device identifier numbers not provided).Among all patients, observations included: one lead dislodgement on postoperative day 1; four intermittent sensing failures; an increase in the mean myocardial threshold when compared between implant and explant (threefold increase in children and sixfold increase in adults).Based on the available information medtronic product was associated with the adverse event(s).The physician/author(s) made no statement adverse event or required intervention related to these observations.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Citation: ohm et al.New temporary atrial and ventricular pacing leads for patients after cardiac operations.Journal of thoracic and cardiovascular surgery.Vol 110, issue 6, p.1725-31, dec 1 1995.Doi:https://doi.Org/10.1016/s0022-5223(95)70036-6.Earliest date of publish used for date of event.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 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.

• Brand Name: MEDTRONIC TEMPORARY PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12701191
• MDR Text Key: 281082466
• Report Number: 2025587-2021-03161
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 10/26/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TEMP LEAD
• Device Catalogue Number: MDT-TEMP LEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening